ROLE OF A PEDODONTIST IN CLEFT LIP AND CLEFT PALATE REHABILITATION – AN OVERVIEW

Cleft lip and palate is one of the most common congenital anomalies requiring multidisciplinary care. Such anomaly is associated with many problems such as impaired feeding, defective speech, hearing difficulties, malocclusion, dental abnormalities, gross facial deformity as well severe psychological problems. Cleft of the lip and palate is one of the complex conditions that occur at a functionally potential area in the orofacial region and also at such a crucial time that strategic interventions at the right age by the concerned specialists becomes the need of the hour. Pediatric dentist is an integral part of the cleft rehabilitative process right from the neonatal period upto the phase of permanent dentition. Being well versed with a childs growth and development, both physical and mental, a Pedodontist helps in restoring function and esthetics in a cleft child, in a most empathetic way. This article describes the enormous challenges faced by these innocent souls and the vital role played by a Pedodontist, to provide comprehensive cleft care, be it preventive, restorative, or interventional care, in order to achieve the best possible outcome and meaningfully improve their quality of life.


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Problems associated with cleft A patient with a cleft, unfortunately, is faced with a multitude of both anatomic & physiologic problems including feeding, speech, hearing, appearance, dentition & quality of life. 11 They are also reported to have significant behavioural and emotional problems resulting in reduced social competence, impulsive behavior, learning or cognitive disabilities. The chief complaints of these patients are mainly deformed face, inability to feed, and nasal regurgitation of fluids. 12 Because of deformity of the face, these patients are often seen as an object of ignorance and are often separated from their normal counterparts in society. It may result in lifelong psychological trauma. Hearing defects are very frequently observed due to disorder of the middle ear. Speech problems are observed along with velopharyngeal insufficiency, hypernasal voice and difficulty in articulation. Moreover, early palate repair results in retarted maxillary growth due to surgical trauma to growth centres and periosteum. Early closure cases might lead to decreased antero-posterior maxillary dimention or even severe malocclusion to dentofacial deformity. Patients with complete cleft lip & palate exhibit a more normal dental arch when palate is operated at a later stage ie, after growth phase, than those operated in infancy. Maxillary collapse & failure of midface growth could be eliminated if surgical closure of palate is postponed until 4 years of age. But there are certain drawbacks like delay in repair resulting in speech defect, articulation & hearing problems.Thus the best balanced results are obtained by repairing between one & a half years of age. Sometimes they are also faced with difficulty in breathing while sleeping known as Sleep apnoea. 13 The Dental problems mainly include congenitally missing teeth, anodontia or hypodontia, neonatal teeth, ectopic eruption, supernumerary teeth, anomalies of tooth size and shape, delayed eruption, ankylosis, micro-and macro-dontia, fused teeth, enamel hypoplasia, difficult oral hygiene maintainance, high risk of caries and gingivitis, deep bite, crossbite and crowding or spacing of teeth. 14,15

Management of Cleft Lip and Cleft Palate
It is very distressing for the parents, once their child is born with a cleft. The psychological and social implications of this congenital deformity could be severe and their management becomes a major responsibility for the healthcare system. 16 The main goal is to restore esthetics and functional impairments associated with cleft. The overall management is challenging & dictates the need for multiple disciplines, to work in unison with their skill & expertise to provide optimal care for the patient. Comprehensive cleft care has two parts-Non-surgical and Surgical therapy. 16,17,18,19,20,21,22,23,24 (Fig.2)

Fig.2:-Comprehensive cleft management.
The American Cleft Palate-Craniofacial Association (ACPA) 25,26 & Cleft Palate Foundation (CPF) recognized by WHO, the American Academy of Pediatrics (AAP) 27 and American Academy of Pediatric Dentistry (AAPD) 28 provide guidelines & standards for cleft related & craniofacial care. The ACPA promotes a interdisciplinary team approach to bring about a complete rehabilitation thus ensuring these children would live a normal life. These teams are composed of qualified health professionals from medical, surgical, dental, and allied health fields working together in a coordinated system. The essential services are mainly provided by the patient care coordinator, pediatrician, plastic surgeon, general surgeon, oral surgeon, pedodontist, orthodontist, prosthodontist, ENT surgeon, neurologist, speech therapist, psychologist, parents, genetic counselor, audiologist, nurse and social worker. 29 (Fig. 3) 885

Fig. 3:-Interdisciplinary cleft care team
Role of a Pedodontist:-Patients with craniofacial anomalies require dental care throughout life as integral part of total rehabilitation process. A dedicated pediatric dentist is best suited to provide the often complex dental care necessary for these patients. Among the members of the team, a pedodontist is a specialized dentist with advanced training to help children with general & special dental problems. They are responsible for overall oro-dental care of the child. It has been reported worldwide that 92% of the programs included the pediatric dentist in the multidisciplinary cleft palate team with the role extending from preventive, restorative to infant orthopedics. The role of pedodontist starts from neonatal period right up to permanent dentition phase. The pediatric dentist facilitates the integration of oral hygiene and dental preventive regimens into the treatment protocol for cleft children to establish desirable habits and oral health before the provision of advanced reparative surgery and complex dental treatment.
For any individual with a craniofacial difference, an early consultation with a pediatric dentist has been highly recommended. The AAPD suggests that for infants with a cleft, the first dental visit should occur usually right after birth to provide optimal dental care. A pediatric dentist is usually the first dental specialist with whom the parents will encounter. A pedodontist usually discusses the traditional dental problems associated with clefts with parents and also guides regarding proper timing of spacialist referral. In addition, a pedodontist interacts with the patient & family on a regular basis that allows input to the cleft team regarding changes in the patient"s behavior, sleep, academic performance & social interactions. A Pedodontist"s active participation in the interdisciplinary cleft team is very important as a specialist being trained in every aspect of a child from physiology to psychology. 30,31,32,33,34,35,36,37,38 Sequence of pediatric dental treatment For convenience, Pediatric dental treatment for a cleft child is divided into four stages, corresponding to the dental developmental stages along with craniofacial growth. 35,39,40,41,42 (Fig. 4) 1. Stage I: Initial management (birth to 2 1 ∕ 2 years of age) 2. Stage II: Primary dentition(2 1 ∕ 2 to 6 years of age) 3. Stage III: Mixed dentition (6 to 12 years of age) 4. Stage IV Permanent dentition (12 years of age to the late teen years) 886

Fig. 4:-Flowchart depicting Role of a Pedodontist
Stage I: Initial Management:-(Maxillary orthopedic stage: Birth to 18 months) Management of Neonate Immediately after the child is born with a cleft, the mother becomes highly anxious due to the difficulties faced during the process of feeding the neonate. In addition, neonatal respiratory obstruction is seen which is attributed to a very small and posteriorly displaced mandible. All these make it difficult for the infant to maintain adequate nutrition, which may even lead to failure to thrive. The current management protocol involves reparative surgery within the 12 months of life. But there is a direct relationship between decreased body weight and complications in surgery which therefore necessitates early interventions through conservative means, aimed at decreasing these complications that might arise due to inadequate feeding. 43

Feeding Obturator Therapy
Obturator is a prosthesis used to close a congenital or acquired tissue opening primarily of the hard palate and/or contiguous alveolar & soft tissue structures. Ambroise was the first one who used obturator as artificial means to close a palatal defect as early as 1500 AD. A feeding obturator is a prosthetic aid that is designed to obturate the cleft & help a cleft child to eat properly. It creates an artificial palate, against which the infant can press the nipple and suckle milk. It helps to create an intraoral negative pressure thus helping in swallowing. It provides a rigid platform thereby preventing the tongue from entering the defect and interfering with spontaneous growth of the palatal shelves. It separates the oral & nasal cavities, hence reduces nasal regurgitation and incidence of choking. Obturators are believed to improve infant feeding, growth & nutrition and also contributes to the development of the jaws and speech. Furthermore, an obturator also provides maxillary cross-arch stability and prevents arch collapse after definitive lip surgery, thus help in achieving a better functional and esthetic outcome. A study by Jones et al (2003) reported that, maxillary obturators constructed to facilitate feeding for infants with UCLP & BCLP, lead to reduced nasal discharge, reduced the time required and difficulty experienced by the parents while feeding their infants. 3,44,45,46 887 Steps in fabricating a Feeding Obturator 1. This is ideally accomplished as soon after birth as possible. Before making any impression, the palate as well as inner walls of cleft is painted with petroleum jelly & the cleft defect blocked with a clean soft gauge piece to prevent lodgement of impression material into defect area. 2. For diagnostic impression, a softened wax sheet is adapted intraorally on infant"s maxillary arch using thumb and index finger. A stone model is poured to fabricate a modified stock tray with handle which is used to obtain primary impression. Cast is poured & a custom acrylic tray is fabricated. 3. During impression process, infant is held either upright or with face down towards floor to prevent aspiration of excess material which eventually might cause vomiting & asphyxia. It is noted that infant should be crying during impression making, thus maintaining a patent airway continuously throughout the procedure. Appropriate emergency equipments including forced oxygen, suction, standard airway management equipment should be available nearby. Sucking motions made by the infant during impression making helps to obtain better moldability. Final impression is preferably made with a putty material. The master cast should exhibit good anatomic detail of entire maxillary arch. Excessive undercuts are blocked with modeling dough or wax.
(Case report 1, Fig. 5.a-e) 40 47 (Fig. 6. a-h) Impression of the maxillary arch was made with polyvinyl siloxane putty material, used because of its high viscosity reducing the danger of aspiration as well as relatively satisfactory duplication of finer details. Impression was poured with Type V dental stone. Undercuts blocked with wax. The vacuum tray was fabricated in a vacuum former machine using a low-density polyethylene sheet & tightly adapted to the cast. The tray was then trimmed to remove excess material. Here a vacuum tray was chosen over an acrylic obturator because of its added advantages of being light weight, moldable, good fit to palate and decreased possibility of soft tissue injury due to its soft texture. Following this an 8-inch floss was attached to the feeding obturator to provide a safety mechanism in case of gagging or accidental slippage and swallowing. The appliance was positioned in the patient's mouth and parents were instructed about it"s placement, removal and cleaning. Thereafter, the mother was asked to feed the infant. It was seen that the child was successfully able to feed with the feeding obturator appliance in place.
888 Fig. 6(a-h) :-Feeding obturator appliance for a BCLP patient made with low-density polyethylene sheet fabricated in a vacuum former machine. Case Report 3: A feeding appliance for a newborn baby with cleft lip and palate (by Abhay Agarwal et al, 2010. 48 (Fig 7. a-g) Due to lack of retention, occationally a stainless steel wire is incorporated in the acrylic plate & extended bilaterally following the cheek contour for the purpose of extraoral retention. These wings can be stabilized against the cheeks using adhesive tape.

Premaxillary Orthopedic Therapy (Birth to 4 or 5 months)
In some cases of Bilateral clefts, the infant has a premaxillary segment positioned severely anterior to the lateral maxillary arch segments, or deviated laterally to one side of the cleft defect (Fig. 8,9). This presents a difficult clinical challenge for the surgeon before surgical closure of the lip. If lip surgery is undertaken with the premaxilla in such an abnormally forward position, the chances of lip dehiscence are increased. In this aspect, Hofman, as early as 1686, described use of a head cap & premaxillary strap to reposition premaxilla. 26 This type of apparatus is useful for both anteroposterior as well as vertical repositioning. Presently, premaxilla is retracted by an elastic chain & lateral alveolar segments expanded with activated expansion device. Patient is recalled weekly for 4 to 7 weeks for activation of the elastic chain. The appliance is removed at the time of patient"s primary surgical lip repair, which is approximately 6 months of age. 49 ( Fig .8. a-h) In this, an anteriorly positioned maxilla and laterally displaced premaxilla is shown. Immediately on being reported (within 2 weeks of birth), an impression of infant"s maxillary arch has been made for fabricating intraoral obturator. After delivery of obturator, infant is allowed to get accustomed with it for 1 week. At second appointment, infant is fitted with a premaxillary retraction (active) appliance.  40 (Fig 9. a-g) A bonnet-and-strap appliance is usually made to provide "headgear" anchorage for premaxillary retraction. The desired movement could usually be accomplished within 6 to 8 weeks. In many cases a soft, elastic tape (Microfoam Tape) could be useful for retraction in a simpler manner than with bonnet retraction system. The advantage being ease of fabrication, however, it did not afford same control of force, hence could not be used in all instances. In this case report, a laterally protruded premaxilla in an BCLP infant has been presented, where premaxilla must be positioned in facial midline before retraction because a straight extraoral force would not do that. Moreover, this also decrease the risk of distorting a vomer stalk and waive off the need for a surgical premaxillary setback, a procedure associated with possible growth attenuation and other complications. Optimum premaxillary positioning may even eliminate need for a staged lip closure (lip adhesions before definitive lip surgery) thereby decreasing total hospital time and cost. The appearance of nose and lip is usually improved because lip could be repaired under less tension as alveolar segments are already aligned symmetrically. Here, primarily an external acrylic "bulb" prosthesis has been planned. The appliance was fitted over laterally protruding premaxilla & anchored to infant"s head with a bonnet appliance. By application of sequentially increasing differential forces with elastic straps attached to bulb prosthesis, premaxilla was brought into facial midline in 3 to 4 weeks with the appliance in place for 24 hours a day and removed only for feeding. Following this, bulb appliance was replaced by single elastic straptherapy to improve anteroposterior relationship before definitive lip closure. Over next 1 to 2 months, equal pressure was applied on the still protruding premaxilla, to retroposition it into a more normal position between the lateral segments. Premaxillary segment at completion of straptherapy could be seen in Fig.9. Sequential models at 1 week (initial presentation), 1 month (completion of bulb therapy), and 4 months (completion of strap therapy) have also been shown.

Maxillary Orthopedic Therapy (Birth to 9 months) Presurgical Infant Orthopedics (PSIO)
Infant orthopedics is done in patients with a very wide cleft gap, during the first 18 months which is a period of most intensive growth. Various appliances have been developed to help reposition the cleft segments and modify the defect before initial lip repair & assist in obtaining a better surgical outcome. This concept was introduced at University of Glasgow by Kerr McNeil in 1954 as an adjunctive neonatal therapy aiming at nonsurgical reduction of alveolar cleft size. The rationale behind "Maxillary Orthopedics" as described by McNeil, Burston & Rosenstein is "early segment alignment allowing the maxillary halves to develop normally even though normal bony union is not present". The primary purpose of the appliance prior to lip closure is not to proliferate tissue or initiate growth but to guide the maxillary segments into proper spatial position with each other & with the mandibular arch. 50,51 In some cases, a PSIO appliance could be additionally used as a feeding plate for cleft infants.

Presurgical Naso Alveolar Molding (PNAM)
Multiple PSIO techniques exist, among which presurgical nasoalveolar molding (PNAM) therapy is provided by the pediatric dentist. The first PNAM appliance was designed by Grayson et al. (1999). Nasoalveolar molding is a nonsurgical method of reshaping the gums, lip, and nostrils before definitive lip & nose repair, thus reducing the 890 severity of cleft. Before introduction of this concept, repair of a large cleft gap required multiple surgeries between birth & 18 years of age, putting the child at risk for various complications. With advent of PNAM, all these could be reduced. Surgery is performed only after the molding is complete, approximately 3-6 months after birth. Fig. 10 shows picture of a child before and after PNAM therapy. 52,53,54,55,56 Fig. 10:-Reduction of cleft size after Naso alveolar molding Objectives of PNAM therapy 1. Reduction of cleft size by guiding growth and functional rehabilitation 2. Restore physiologic continuity of the dental arch to maintain oral and dental health 3. Achieve an optimal alignment of cleft segments within first few months of infancy before lip surgery 4. To allow a surgical repair with minimal tension and reduced scar formation. 5. To reduce the protrusive position of the alveolar process (premaxilla) 6. Prevent tongue from seating into cleft region, thus facilitating transverse growth of palatal shelves 7. To actively mold and reposition the deformed nasal cartilages 8. To lengthen the deficient columella and correct the alar cartilage displacement 9. To reduce the need for secondary alveolar bone grafting.

Rationale of PNAM Therapy
• There is high degree of plasticity in neonatal cartilage due to high levels of hyaluronic acid. Hyaluronic acid level increases with increase in estrogen level. Immediately after birth, neonatal level of maternal estrogen is highest. Therefore first 2-3 months after birth is the ideal period for active cartilageneous soft tissue moulding. The increase in levels of hyaluronic acid in the fetal circulation continues for about 6 weeks after birth, after which the estrogen levels starts dropping down. This Hyaluronic acid has the ability to alter the elasticity of the carlilage, ligament & connective tissue by breaking down intercellular matrix (Matsuo, 1988).
• According to Chondral Modeling hypothesis by Hamrick (1999), active moulding of nasal cartilage stimulates immature nasal chondroblasts, producing an interstitial expansion, thereby improving nasal morphology. PNAM takes advantage of flexibility of cartilaginous septum in first few weeks of birth, as it is favourable for active molding & repositioning of nasal cartilages.
• During this time it is relatively easy to apply external traction by means of controlled forces to rotate the lower part of the premaxilla to a more surgically advantageous position & to produce a normal dental arch alignment by approximating the alveolar cleft. Prognosis of PNAM procedure is highly dependant on the age at which it is started & patient compliance. Thus, the favourable time to start PNAM procedure is immediatey after birth & if started beyond first six weeks, outcome may not be very appreciable.

Principle of PNAM Therapy
PNAM works on principle of "Negative sculpturing" & "Passive molding" of alveolus & adjacent soft tissue. (Fig. 11. a-f) As pressure is exerted on the anterior segments of the maxilla by the repaired lip, orthopedic molding of the segments can be achieved. In unilateral cases, the force applied to the greater segment by the intact lip molds that segment around to approximate the lesser segment. This molding is facilitated by the obturator or NAM plate, which provides a fulcrum around which the anterior portion of the greater segment rotates. At the same time the appliance resists any tendency for the greater and lesser segments to collapse toward the midline. 57,58 891 Passive molding A custom made molding plate of acrylic used to gently redirect the growth of the alveolus to get the desired results later on.

Negative sculpturing
Serial modifications made to the internal surfaces of the molding appliance with addition or deletion of material in certain areas to get desired shape of the alveolus, and nose.

Fig. 11(a-f):-Schematic diagram representing Biomechanics of NAM for UCLP & BCLP patients
Steps in NAM plate fabrication Impression making The different materials that could be used for impression making of cleft are impression compound, elastomeric and polysiloxane impression material due to manageable setting time and excellent tear strength. Wash technique using Light body impression material might cause gagging. Irreversible hydrocolloid (alginate) is not used due to poor tear strength and possibility of the set material to break into small pieces and occlude the air passage. A medium bodied silicone impression material is a preferred material of choice. A diagnostic impression is made usually by carrying the impression material using two fingers or even with a small tablespoon. The infant is fully awake without any anesthesia. Head is gently held in slightly upright position. Infant is held upside down ie, head facing a downward position towards the floor, to prevent aspiration, prevent tongue from falling back and to allow fluids to drain out of oral cavity. Head to be supported throughout the procedure. One person cradles the infant securely around chest & torso supporting the head & neck, while another obtains the impression. Excess material in posterior area should not block airway as infants are obligate nasal breathers. Infant should cry while making the impression which means the airway is patent. High volume evacuation should be ready. Nearby hospital set up is preferable with a surgeon available to handle any emergency situation ( Fig. 12.a-i). Once the impression is set, the oral impression tray along with nasal impression should be taken out in single swift movement to prevent dislodgement or separation. Following this two casts are carefully poured, one for fabrication of prosthesis (working cast) & other for patient"s permanent record (study cast)to assess progress of molding. 59 892

Retentive taping
It should be secured extraorally to cheeks using adhesive surgical tapes. With orthodontic elastics attached to one end, the tape is pulled in a specific direction from the retentive button to the cheeks to provide optimal retention to the molding plate.

Addition of Nasal stent
Clinically it has been suggest to start the nasal molding from day 1 along with alveolar molding to avoid wasting of the golden window period when the infant"s nasal cartilage has high levels of hyaluronic acid. The Grayson technique starts nasal molding when alveolar gap is reduced to 5-6mm, whereas the Figueroa technique performs nasal & alveolar molding at the same time. 61 The stent is made of 0.036-inch round stainless steel wire & takes the shape of a swan neck. The hard acrylic component is shaped into a bi-lobed form resembling a kidney. A large nasal stent is used in Figueroa"s technique to reduce chances of ulceration. In BCLP cases, two nasal stents are required. Focus is also there on non-surgical lengthening of the columella. The columellar length at birth is 0-2mm, following NAM, it increases to 4-7 mm. The usual length of columella at this age group is 3.2mm, but overcorrection is helpful to compensate for post surgical relapse. 33

Appliance Activation & adjustments
Weekly visits are required to modify the molding plate to guide the alveolar cleft segments into the desired position. Not more than 1mm of modification should be made at one visit. As alveolar segments start getting approximated, adjustments for the major segment include selective removal of about 1mm of hard acrylic along medial surface & addition of hard acrylic to external surface of molding plate. Exactly opposite to be done with respect to minor segment. A layer of soft denture liner is added to the hard acrylic for comfort. Mesio-lateral position of nasal stents is also adjusted as it lifts the nasal tip. In bilateral cases NAM is done in stages. Firstly, retropositioning of everted premaxilla is done into space between lateral alveolar segments. Secondly, after approximation of alveolar segments, nasal stents entering nasal apertures are built from anterior rim of oral plate. This provides support to nasal dome, shapes alar cartilages & elongates deficient columella. 40 (Fig 14. a-d)

Recall and follow up
Instructions regarding daily appliance care, feeding the infant while appliance is in situ, possible complications & their management are explained to parents. They are advised to keep the plate in infant"s mouth full time & take it out for cleaning at least once a day. Patient should be recalled on weekly interval for progress assessment, necessary adjustments & motivation. Appliance retention, posterior extent of plate to prevent gagging & improvement in suckling ability should be checked. Duration of molding therapy is dependent on severity of initial cleft deformity, age at which PNAM has been commenced, type of case (unilateral/ bilateral) & parent cooperation. Fig. 14(a-d):-Optimal maxillary arch symmetry obtained by NAM Therap for an UCLP patient

Advantages of NAM Therapy
Reduces the size of cleft gap, thus improving surgical outcome. Primary nasal surgery becomes simpler after NAM & also provides stable long-term results. Gingivoperioplasty (GPP) could be performed without need for extensive tissue dissection. PNAM used in conjunction with GPP helps to avoid additional bone grafting surgery or early nose revision surgery. Also allows controlled, predictable repositioning without Lip adhesion surgery. In Bilateral cleft patients, PNAM combined with columellar lengthening eliminates the need of separate columellar elongation surgery, improves esthetics by reduced scar formation as well as enhances the infant"s ability to properly feed & gain weight. 62,63 894

Complications of NAM Therapy
Occasionally there is a risk of obstructing the airway caused by dislodgement of molding plate. Excessive pressure from appliance can cause ulcers, irritations or bleeding of oral/nasal mucosa. Fungal infection can result due to poor oral hygiene maintainance. Extra-oral taping can cause rashes on the cheeks, this can be best managed by wetting the tape before removal, or applying aloe vera gel or anti-rash cream. During nasal moulding, excessive pressure applied or improper positioning of the stent can lead to mega-nostril (gap > 6 mm) or inflammation of nasal epithelium. Excessive rotation of the lesser alveolar segment in its approach to meet the greater segment in a perpendicular manner, might result in asymmetric T-shaped configuration. Compliance of the patient, parents or caregivers is a key factor for successful outcomes.

Advancements in NAM Therapy
Modified muscle-activated maxillary orthopedic appliance for Presurgical NAM in infants with UCLP Sanjay Suri and Bryan D Tompson (2004) 64 conducted astudy to describe a treatment approach for PNAM in unilateral cleft patients. This approach uses a plate held in with outriggers,which prevents the cleft-widening effect of the tongue, helpswith tongue tip placement, and utilizes the functionalmovements of the facial musculature to guide and relocate themajor segment medially to its normal position. Nasal moldingis undertaken after most of the latero-medial correction of the alveolar position. They concluded that this technique helps toimprove alveolar position, nasal septum alignment, nasalsymmetry, and nasal tip projection prior to lip repair.   (Fig 16. a-h) 895 Fig. 16(a-h) :-Active alveolar molding appliance with expansion screw

Dynacleft and Nasal Elevators
Vinson LA (2016), did a study on PSIO in CLP care. Dynacleft is a premade nasoalveolar molding device which couldbe used to successfully mold upper lip, alveolus & nose prior to CL repair. Unlike tape, Dynacleft offers benefit of being able to provide a constant approximation force with an elastic center allowing it to conform to a baby"s mouth better due to its ability to expand & contract. Additionally, controlled force that it provides to prolabium & premaxilla could improve surgical results & decrease necessity of early lip adhesion surgery. (Fig. 17. a-c)

NAM therapy with Computer Aided Design (CAD-NAM) Xin Gong & Quan Yu et al. (2012) did a study on Correction of maxillary deformity in infants with BCLP using
Computer Aided Design (CAD). (Fig. 18. a-j) Treatment planning & appliance design were accomplished with CAD-NAM, which enabled accurate analysis of movements in multiple planes. Guiding principle was application of constant low-grade controlled force in the right direction to reshape & reposition anatomic structures. Maxillary alveolar segments were directed to their final & optimal positions. On analyzing it"s effectiveness on maxillary alveolar morphology in infants, it was found that CAD-NAM effectively reduced cleft gap, corrected maxilla midline & improved sagital length of maxilla. Alveolar height decreased significantly after treatment, which indicated that traction force of the appliance may have obstructive effects on vertical growth of alveolar bone. Fig. 18(a-j):-NAM therapy using CAD-NAM appliance Thus Naso Alveolar Molding technique, when considered soon after birth, has been significantly shown to improve surgical outcome of cleft patients compared to other techniques of presurgical orthopedics. 61 PNAM should be performed prior to primary lip repair. This usually gives psychological reassurance to parents and enhance the future functional & esthetic outcome. It reduces the need for soft-tissue revision surgeries later on & also the overall treatment cost.

Stage II: Primary Dentition Stage Primary alveolar bone grafting
After definitive lip closure at about 3 months of age, maxillary arch collapse in UCLP and BCLP patients is common. It is attributed to increased tension placed on segments by repaired lip. 75% of the patients with CLP have an anterior alveolar bone defect and deficient alveolar bone support might also contribute to collapse of alveolar segments. To prevent this, an obturator is used to provide cross-arch stability & support as well as achieve orthopedic molding of maxillary segments. Furthermore, surgical reconstruction of cleft with bone graft also becomes necessary for eruption of teeth adjacent to the defect, for orthodontic and prosthodontic rehabilitation and for closure of symptomatic oronasal fistulas if present. When the maxillary segments are in good alignment and abutted across the cleft sites, the patient is ready for primary alveolar bone grafting. This generally occurs by 6 to 9 months of age. Primary bone grafting refers to bone-grafting procedures involving alveolar cleft defects in children younger than 2 years of age (Fig. 19. a-d). According to Rosenstein & colleagues, minimal dissection technique should be implemented and care should be taken not to disturb the vomeropremaxillary suture, otherwise it might cause impaired postnatal maxillary and midfacial growth leading to development of crossbite and pseudoprognathism. In non-grafted clefts, maxillary arch collapse is common after palatoplasty. Primary alveolar grafting establishes maxillary arch continuity early in life by producing a one-piece maxilla rather than two or three segments, facilitating conventional orthodontic treatment in future. These grafts also provide bony support during eruption of primary lateral incisors through the cleft site. Hence bone grafting is considered an important step in the current protocol of cleft management. 40,67,68 Fig . 19(a-d):-UCLP & BCLP patients where primary alveolar bone grafting procedure is beneficial.

Routine dental care
Primary teeth are important for chewing, aesthetics, and speech. They assist in guiding the permanent teeth to erupt into their proper place in dental arch. Early removal of primary teeth in cleft children is particularly contraindicated because of possible space loss, making future orthodontic treatment more difficult. It is thus important to make the parents understand the value of good dental health and initiate Infant oral healthcare program. During primary dentition stage, children should begin to have periodic dental check up at 6-month interval with the pediatric dentist. Establishing correct dental habits from an early age helps to ensure health of both primary and permanent dentition. 69

• A study by Kamble & Hiremath et al (2017)
showed statistically significant increase in prevalence of dental caries in cleft children, significantly higher mean DMFT & poor oral hygiene in operated children due to reduced access for cleaning upper anterior teeth after surgical repair. It was concluded that, cleaning in the potential areas of plaque accumulation around the cleft regions hould be properly demonstrated. A more rigorous approach to be advocated for prevention of dental disease in these high-risk children subjecting to regular checkups, oral hygiene practices & diet counseling, appropriate fluoride supplementation & timely referral for secondary care whenever required. 70,71 • Use of Fluoride: A low-fluoride children's toothpaste containing no more than 600 ppm fluoride is recommended for children under 6 years of age to reduce the likelihood of enamel opacities in the permanent teeth. Children with a high risk of developing caries should use a standard toothpaste (1000 ppm fluoride). A twice-yearly professional application of topical fluoride varnish is recommended.

Stage III: Mixed Dentition Stage Management of deficient midfacial growth
Patients with maxillary hypoplasia secondary to orofacial cleft present multiple challenges. Traditional orthodontic or orthopedic approaches to treat these patients are sometimes successful in obtaining stable occlusal relationships but often falling short of expectations with respect to facial balance & esthetics. The midfacial deformities due to primary cleft surgeries include transverse maxillary deficiency with crossbite, midfacial retrusion, reduced antero-897 posterior development, mandibular prognathism and concave soft tissue profile. 72 The various treatment protocols that are usually followed for correcting this secondarily acquired discrepancies are-

Protraction of mid face
In patients with severe hypoplastic maxilla following cleft palate surgery, major maxillary advancement with conventional LeFort I osteotomy gives rise to extreme discripancies making stabilization difficult & added effect of palatal scarring results in significant surgical relapse. So alternative technique using patient"s growth potential gained much stable and satisfactory results. Maxillary protraction is achieved orthopedically by using a face mask at about 8 years of age. Though the skeletal changes are limited, they produce marked improvements in soft tissue profile. 73 (Fig. 20. a-d)   Fig. 20(a-d):-Maxillary sagital protraction with Face mask therapy Palatal expansion (Rapid maxillary expansion/ RME) Expansion of palate was first achieved by Emerson C. Angell in 1860. Expansion of dental arches can be classified as dental expansion, skeletal expansion and passive expansion. Rapid Maxillary Expansion or RME, also known as split palate, is an example of skeletal expansion and produces skeletal changes rather than mere tipping of the teeth. It results in separation of the midpalatal suture moving the maxillary shelves away from each other. 74 (Fig. 21. a-d) Indications of RME Palatal expansion is advised in CLP cases with maxillary transverse deficiency, restricted growth of maxilla leading to posterior crossbite, maxillary arch collapse, constriction and retrution. 75 Correction achieved through RME is often with the help of reverse pull headgears. RME is unique among therapies, since the bony movements ramify beyond the dento-alveolar complex. It can also have fundamental effects on improving compromised respiration in certain cleft individuals with medical conditions related to orodental structures. These include nasal stenosis, poor nasal airway, septal deformities like Deviated Nasal Septum, recurrent infections of ear, nose & maxillary sinus, allergic rhinitis etc.There is an increase in intra-nasal space or width of nasal cavity following RME. Thus airflow resistance is believed to reduce by 45-60%, thereby improving nasal breathing.

Contraindications of RME
Ossified mid-palatal suture, single tooth crossbite, true unilateral crossbite, patients with severe antero-posterior skeletal discrepancies, vertical growers with steep mandibular plane angle, associated with mandibular retrognathism, periodontally weak dentition, any soft tissue pathology in pressure bearing area.

Timing of ossification of mid palatine sutur
A patent midpalatal suture is considered highly responsive to transverse forces, whereas an ossified or integrated suture is not only unresponsive to non-surgical expansion, rather it could be potentially harmful to the periodontium. Thus RME should be initiated prior to ossification of mid palatal suture. Melsen (1975) reported that transverse growth of mid-palatal suture continues up to 16 years in girls & 18 years in boys. Earliest closure of mid palatine suture was observed in a girl aged 15 years. While oldest person with an un-ossified suture was a woman aged 27 years. Certain primary cartilages remain at junction of various bones & sutures acting as important growth sites.These are replaced by bones later in life. These areas known as "synchondrosis", present at midpalatine suture site, are probably the reason for late ossification & maturation of this suture. 74

Activation schedule
It is usually done by opening the screw in appliance using a key provided by manufacturer. Opening the screw by a quarter turnor 90 degree (one turn equal to ¼ turn of central bossing) brings about a linear movement of 0.18mm which is less than width of periodontal ligament ie, about 0.25mms. The pattern of threading on either side is of opposite direction. Thus turning the screw withdraws it from both sides simultaneously causing two halves of screw to move apart producing desired force for expansion. In children, expansion screw can be activated twice a week. Since width of periodontal ligament is narrow in adult patients, activation should be done only once a week, to move 898 the teeth slowly. An increase in maxillary width of up to 10mm can be achieved by RME. The rate of expansion is about 0.2 to 0.5mm per day.

Schedule by Zimring and Isaacson
In young growing patients, two turns each day for 4-5 days and later one turn per day till the desired expansion is achieved. In non growing adults, two turns each day for first 2 days, one turn each day for next 5-7 days & one turn every alternate day till desired expansion is achieved.

Schedule by Timms
For patients upto 15 years of age, 90 o rotation in the morning and evening. In patients over 15 years, 45 o activation 4 times a day has been recommended.

Procedure of Distracion osteogenesis
Primarily a bone is surgically osteotomized or fractured & the ends are gradually distracted away from each other with a regular controlled force. A device known as distractor is attached to both sides of osteotomed bone, which is gradually adjusted over a period of days or week, through slow application of force, resulting in new bone formation between the two cut ends of the bone as well as enhanced soft tissue adaptation. This bone formed may initially be immature but later transforms into mature strong bone similar to remaining skeleton. 76 (Fig. 22. a-j)

Distraction Osteogenesis Versus Orthognathic surgery
This procedure comes as an alternative to or almost replaces orthognathic surgery. When compared, the greatest advantage of DO is that during this slow process the soft tissue envelope of bone has the ability to accommodate the gradually enlarging underlying skeletal framework. That means soft tissue remodelling also occurs simultaneously along with new bone formation. That is the uniqueness of this technique because it greatly contributes to long term stability of the whole procedure & also reduces all potential damages or complications that can be caused by a definitive invasive surgery.
899 Fig. 22(a-j) The rhythm of device activation may vary from one cycle per day of 1mm to 0.5mm twice daily.

Healing index/ Stabilization period/ Consolidation period:
It is the number of days or months from the operation when the distraction device is kept in neutral position or can be removed so as to expose the bone to unprotected load bearing forces. This period generally ranges from 4-6 weeks or can be extended to 6-10 weeks if required.

Advantages
DO a safer surgical technique & a more conservative procedure, decreases operating time, length of hospitalization & morbidity. There is no need for autogenous bone grafting & could be done in young patients rather than waiting for growth completion as done in case of orthognathic surgery. It has a wide range of application in correcting congenital & acquired craniofacial deformities as well as benefit of associated soft tissue growth like muscle, mucosa, skin along with bony tissue.

Complications
With DO, occasionally there might be injury to a developing tooth bud or a vital structure like inferior alveolar nerve, or a pin track infection in case of extraoral devices. Early removal of the device might lead to fracture of jaw due to inadequate bone formation and rarely fibrous union might occur instead of mature bony union.

Secondary Alveolar Bone Grafting
An orofacial cleft repair is not only repair of cleft lip or cleft palate, a repair of cleft in dental alveolus is equally essential. Surgical closure involves approximation of soft tissue flaps over bony defect to unite separated segments. This however, does not result in bone formation between two ends of cleft. As mentioned by Bergland et al, establishing a bony continuity produces an improved environment for further growth & eruption of teeth in defect area. In addition, good bone support in palatal area for denture retention, if that is needed. To accomplish this, it is better to place some bony graft material into the defect that can induce bone formation. Secondary alveolar bone grafting is now a common practice in treating CLP patients. Ideal goal is to improve dental arch form & achieve non-prosthetic rehabilitation of dental arch. Successful grafting provides an osseous environment to permit spontaneous eruption of canine into the grafted area. Among other benefits (a) provides firm bony support for alar base of nose improving symmetry & facial esthetics (b) closure of oronasal & nasolabial fistulas-that prevents reflux, nasal regurgitation, reduces frequency of infections and improves speech. (c) Stabilizes premaxilla after infant orthopedics in BCLP cases (d) decreases maxillary collapse & need for orthognathic surgery but facilitates secondary corrective procedures like osteotomy, if required (e) also provide adequate bone volume for future dental implant. 900

Ideal Timing
Timing of bone graft surgery is highly variable & does not depend on chronological age. Rather, dental development age is important that affects the outcome (Dawson et al, 2003).  Early Secondary bone grafting is done between 2 and 4 years of age  Secondary bone grafting is done between 4 and 15 years of age and  Late secondary bone grafting refers to reconstruction of residual alveolar cleft defects in adults.
It should be undertaken during mixed dentition stage, before eruption of canines or when permanent lateral incisor or canine tooth roots are approximately one-third developed. Since sagittal & transverse growth of anterior maxilla is completed by 8 years & lateral incisors erupt by 8-9 years & canine by 11-12 years of age, currently alveolar bone grafting is performed by 9-11 years of age.

Source of bone graft material:-
Materials placed into the defect may be either any autogenic or allogenic bone material or occasionally synthetic bone inducing material. Any autologous cancellous bone is considered the best source of bone graft material. Among them the corticocancellous graft from anterior portion of iliac crest is usually the preferred donor site in most cases. The other sources are-rib, tibia, cranium& the mandible. 9,77 (Fig. 23 a-h)   Fig. 23(a-h):-Secondary alveolar bone grafting procedure in cleft patient are moved into a more desirable position to allow successful grafting of bone. If lateral incisors are congenitally missing, space would be made for a pontic. 78 Sometimes closure of space is recommended where a permanent tooth is missing. Expansion of collapsed segment to improve surgical access to graft site is carried out in this stage. This way posterior crossbite is corrected. Correction of jaw relationship using facemask therapy in mild maxillary deficiency along with control of oral habits could be initiated. Functional shift or space loss after premature loss of primary teeth could be corrected. An increased tendency towards a Class III incisal relationship may become more apparent. Anterior crossbite could be corrected using removable or fixed appliance in order to avoid functional mandibular displacement or retardation of maxillary growth due to "locked in" maxilla. Milestones of growth & development in a cleft child to be monitored. Skeletal & dental components to be evaluated during each dentition stage, to determine presence of any developing malocclusion.

Stage IV: Permanent Dentition Routine Dental care corresponding to Definitive Orthodontics (Phase II Correction)
This stage marks the beginning of definitive orthodontic treatment which is carried out when permanent dentition is fully erupted. The pediatric dentist & orthodontist communicate closely on a regular basis during this phase. The patient needs to be made aware of potential problem of decalcification around orthodontic brackets. Oral hygiene maintainance & effective toothbrushing is reinforced. This coupled with good dietary habits help to decrease risk of tooth decay. Acidic & sugary foods need to be regulated. Prophylaxis & fluoride treatments should be performed. Cavities developed during active orthodontic therapy should be immediately treated. Comprehensive cleft management based on chronological age has been illustrated in Fig. 24. To summarize cleft care and Role of a Pedodontist Children with facial differences have unique identities with something special to add to the community. But they are often seen as object of pity, suffering "emotional burn out" & the pain of "being different". As far as nature is concerned, no congenital anomaly has more complexity & diverse morphological influence in the oral & maxillofacial region than the cleft lip and palate. For a cleft child, the stigma of facial deformity not only affects the individual but also his/her family, peer, acquaintances & society itself. Thus it is our duty to provide them with hope and opportunity as well as boost their confidence to live a balanced and fulfilling life, without the fear of being judged or pressurized to act otherwise.
Cleft treatment requires a holistic approach extending from birth until adulthood, the complexity of the problem requiring a number of health care practitioners both medical, dental and allied healthcare workers to co-operate with each other & ensure comprehensive care for the patient. The ACPA promotes involvement of interdisciplinary cleft team that has been described as union of multiple specialities devoted to the single cause of cleft patient well-being. Among the dental professionals, Pediatric dentist play a vital role right from the neonatal period up to late teen years in rendering a complete oral rehabilitation. Thorough treatment planning, their strategic execution, implementation of skillful behavior managemen, counselingt and providing mental support to cleft affected patients are important aspects of this multifaceted pediatric dental care. 35,79 A Pedodontist performs dual role in both modifying the personal impact as well as improving the surgical outcome.
Being a responsible member of the interdisciplinary team, a Pediatric dentist, serve an important function as they not only provide a dental home for the children & counsel the parents, but also co-ordinate the treatment needs among different cleft specialists. They are one of the constant entities who keep maintaining a high quality oral hygiene status in cleft children that could influence the outcome of other line of treatments proceeding simultaneously. They perform specialized treatment procedures in coordination with other cleft team members. In addition, they ensure that the patients with cleft receive the appropriate dental care. Routine dental care is important to maintain optimal oral and general health in all stages of cleft care. Since patients with cleft are a priority group, a pediatric dentist plays a key role in providing continuuous, high-quality, preventive-based dental care. 80 A Pediatric dentist is an integral part of the cleft rehabilitative process and helps restoring both esthetics & function of the dento-facial system for a cleft affected individual. They provide survellience during the various orofacial developmental stages of the child and performs infant orthopedics, thus reducing the severity of the cleft deformity. The other objectives are to motivate breastfeeding aided with feeding appliance thus taking care of overall nutrition, diagnosing future malocclusions & also informing about specialist referrals in correct timing. 81,82 Pediatric dentists are well aquainted with a child"s overall knowledge, thus in a way by understanding a cleft child"s psychology & different aspects of behavior management, they deliver treatment in a most empathetic way. Be it preventive, restorative or interventional care in management of a cleft individual, a committed pedodontist who follows up all the appointments in time will be the need of the hour. Since speech and hearing difficulties are a common occurrence in these children, it may present as a possible barrier to satisfactorily communicate with them, so a dentist show a lot of patience to establish a good communication, especially in the early years, and thus help in grooming them to be a part of the normal society. Moreover, a transparent communication on a regular basis between the pedodontist, parents & relevant members of the cleft team helps to achieve the best oral health outcome for the patient.

Conclusion:-
Thus, we could see that, the role played by a Pedodontist in comprehensive cleft care, would remain unparalleled, as he is a trained professional & well versed with various kinds of treatment modalities for managing a child patient, both normal and special. There is a constant urge of these innocent children, of receiving social recognition from the "significant others" and return to the mainstream of life. Hence it is high time for all the Pediatric dentists to get involved & actively participate in overall rehabilitation of a cleft affected child, as every child has the fundamental right to his complete oral health and every pedodontist has an obligation to fulfill this faith.