Clinical Ef icacy of Fluoride-releasing Dental Adhesive on Restricting White Spot Lesion: An in vivo Study

Christopher Amalraj Vallaba Doss*1, Akshay Tandon2, Syed Mohamed Sadath3, Palanivel R. M.4, Muhil Sakthivel5, Malik Khurram Shahzad Awan6 1College of Medicine, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, P.O. Box 1982, Dammam 31441, Saudi Arabia 2Department of Orthodontics and Dentofacial Orthopedics, SRM Kattankulathur Dental College and Hospital, SRM University, Chennai-603203, Tamilnadu, India 3Department of Radiological Sciences, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, P.O. Box 1982, Dammam 31441, Saudi Arabia 4Department of Quality & Academic Accreditation, Imam Abdulrahman Bin Faisal University, P.O. Box 1982, Dammam 31441, Saudi Arabia 5Of ice of Vice Presidency for Graduate Studies & Scienti ic Research, Imam Abdulrahman Bin Faisal University, P.O. Box 1982, Dammam 31441, Saudi Arabia 6Department of Quality and Development, College of Medicine, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, P.O. Box 1982, Dammam 31441, Saudi Arabia


INTRODUCTION
Demineralization of the enamel surface is a common complication of orthodontic treatment which can lead to white spot lesion (WSL), (Hadler-Olsen et al., 2012). The incidence of WSL is 49.6% among patients treated with bonded orthodontic attachments, (Gorelick et al., 1982). It is reported that 97.0% of patients exposed to orthodontic treatment had WSL, (Boersma et al., 2005). It could be due to increased accumulation of plaque around the ixed orthodontic device, Willmot (2008) did that led to minimizing the natural self-cleansing, (Rosenbloom and Tinanoff, 1991). Further, prolonged orthodontic treatment increases the risk of WSL. Therefore, WSL requires further invasive intervention for treatment.
Various methods to evaluate white spot lesions such as Macroscopic methods, including clinical examination, photographic examination, Light scattering methods, optical luorescent methods of luorescent dye uptake, using ultraviolet light, laser luorescence and quantitative Light-induced luorescence, (Benson, 2008). Microscopic methods include microhardness testing, polarized light microscopy, microradiography. These microscopic methods utilize extracted teeth for Evaluation which have their drawbacks like treatment delay for the Patient, only Patient requiring extraction can participate, and short duration does not represent the whole treatment period. Among these, luorescence-based methods like Diagnodent proved to be more ef icient in diagnosing lesions invisible to the naked eye and in quantifying the amount of demineralization of the enamel, (Benham et al., 2009;Lodaya et al., 2011).
It is established that Fluoride has been used to decrease the enamel potentiality to decalci ication and it can be administered by toothpastes, gels, mouth rinses and varnishes. However, it requires a Patient's compliance to avoid the incidence of WSL. In order to decrease the incompliance, pharmaceutical corporates have integrated the Fluoride into orthodontic cement to help preventing and reducing the decay around the teeth, (Somasundaram et al., 2013). Casein phosphopeptide-amorphous calcium phosphate was also proposed to reduce caries incidence but it is not yet proven (REF). Argon laser enamel surface attenuation can also be used to prevent enamel decalci ication, but optimal energy density for administration is to be established (REF). Fluoride-releasing adhesives might aid in the prevention of demineralization adjacent to the orthodontic bracket. In vivo effect of a luoride-releasing adhesive (Transbond-Plus, Company Name) with non-luoride releasing adhesive (Transbond-XT, Company Name) on inhibition of enamel demineralization around orthodontic brackets in 20 patients were investigated. It was found that the Fluoride is releasing adhesive resulted in the reduction of demineralization of enamel surface around the bracket, when compared with the traditional adhesive, (Eissaa et al., 2013).
Acidic oral cavity increases the demineralization and the risk of having lesions. Therefore, Fluo-ride helps to inhibit the demineralization of enamel and dentin caries, (Bridi et al., 2016). The pH level is signi icantly associated with demineralization level, (dos Santos Noronha et al., 2016). The combination of calcium phosphate and hydroxyapatite affect the pH of the oral cavity and control the bacterial activities, (Chen et al., 2016). Fluoride release from restorative materials has been extensively researched for many years, (Preston et al., 1999;Featherstone, 1994;Ingram and Frazier, 1980). This is because Fluoride has exhibits anti-cariogenic activity by increasing enamel and dentin resistance to subsequent acid attack as well as inhibit carbohydrate metabolism in dental plaque, (Cate, 2001). Currently, composite resins have been selected as the major direct restorative material in clinical dental practice. Against this background, manufacturers have been trying to develop various luoride-releasing adhesive systems and composite resins, (Imazato et al., 2001). Basdra et al. (1996), studies show that Fluoride is in the highest level of effect during the irst day of treatment used materials containing Fluoride, After this period, a dramatic decline in luoride release was observed in both adhesives, and after 90 days no luoride release was detectable (McNeill et al., 2001), compared luoride release with time from three luoride-containing orthodontic bonding agents in vitro for six months, In the irst days, the luoride release rates has been high. So, materials containing Fluoride helps to decrease the demineralization of enamel. The availability of Fluoride in the oral cavity helps to decrease the lesions, . Fluoride-containing materials release different amounts of luoride ions, depending on the type and composition of the material, (Dionysopoulos et al., 2016).
The purpose of the study is to explore the effect of the Fluoride releasing self-etching bonding system in decreasing the demineralization of enamel surface, as compared to non-luoride releasing bonding system, in due course of time, in vivo. The study also evaluates the in luence of saliva as a predisposing factor for WSL.
Diagnodent, an electronic caries detecting device, which works on the principle of luorescence, is to be used for white spot lesion detection; Changes in the digital readings of the Diagnodent are to be collected for analysis, Evaluation of Incisal and gingival aspect of the buccal surface of tooth and Evaluation for the change in the pH and buffering capacity. The amount of luorescence re lected by demineralized enamel will be shown by the device as a numeric value ranging from (0-99), 3M orthodontic brackets (0.22 MBT) straight wire metal brackets) Many diagnostic tools have been proposed to diagnose these white spot lesions, like visual inspection, tactile Evaluation using probe, ibre optic transillumination which are not completely reliable or do not quantify the carious lesion. LED Light curing unit, Diagnodent unit, Saliva Check reactive strip, Saliva Check test, Teeth on which orthodontic brackets are bonded with Fluoride releasing self-etching adhesive. (Clear-fell)S 3 bond Plus. Patient's saliva is also to be collected at T1, T2 and T3 for measurement of pH and buffering capacity.
Not possible to include all the patients, Teeth with internal and extrinsic stain, Patients on long term medications, Patient planned for surgical procedure, Teeth with defect in histodifferentiation, Teeth with carious lesion/hypoplastic lesion and Glass ionomer restorations on the teeth. Due to More cost to spent patients for treatment because of that not take more patients. Researchers have recommended that luoride availability should be independent of patient cooperation and that the luoride ion should diffuse or dissolve over a prolonged period of time. In addition, it would be bene icial if the luoride ion release were site-speci ic to those areas most susceptible to demineralization, namely, adjacent to bonded orthodontic brackets.

Sampling Techniques
Sample size of 50 patients has been taken.as for the convenience random sampling technique whose are coming to dental College and Hospital and also willing to take treatment. Patients are to be screened at the Department of Orthodontics and Dentofacial Orthopedics, SRM Kattankulathur Dental College and hospital, and suitable patients who fulilled the criteria are selected for the study. Selected patients are divided into two groups as control and experimental group randomly.
The inclusion criteria for this study were; Patients of age group 15-30 years, patients planned for ixed orthodontic therapy, Dentition without any anatomic anomalies, All permanent teeth should be present, Clinically sound tooth, Periodontal healthy teeth without any bony defects, Patient willing to participate in the study, The exclusion criteria were:Individuals with no medical problems or systemic illness, Teeth with internal and extrinsic stains, Patients on long term medications, Patient planned for surgical procedure, Teeth with defect in history differentiation, Teeth with carious lesion/hypoplastic lesion, Glass ionomer restorations on the teeth.
The split-mouth study design was used, and quadrant of Fluoride releasing bonding agent and nonluoride-releasing bonding agent was allocated by random allocation table. There were 2 groups for the study, 25 patients per group were participated.

Pre-Bonding Phase
Patient underwent for complete oral prophylaxis before starting the treatment. Oral hygiene instructions were also given after scaling. Diagnodent, an electronic caries detecting device, which works on the principle of luorescence, was used for WSL detection. The amount of demineralization shown by the device as a numeric value ranged from 0-99 was recorded for diagnosis. The Diagnodent was calibrated for each Patient with a sound/cariesfree site (as recommended by the manufacturer). Baseline Diagnodent readings have to be recorded before attaching the brackets on to the tooth surface. Diagnodent recordings were taken on the incisal and gingival aspect of the buccal surface of control and experimental teeth (T0). The saliva of the Patient was collected and measured for the pH, buffering capacity before the start of the treatment (T0).

Bonding Procedure
The self-etching adhesive (Name, Company) was applied onto the buccal surface of the tooth, at the place of attaching the bracket, for approximately 15s with a disposable applicator. The bracket was placed on to the tooth surface and light-cured for the 20s.

Post-Bonding Phase
The standard orthodontic treatment procedure was carried out, and Patient was called for regular follow up visits 1month, 3months and 6months interval. Diagnodent readings on the gingival and incisal aspect of the bracket were recorded when the Patient came for follow up at one month (T1), three months (T2) and six months (T3). Changes in the digital readings of the Diagnodent were collected for analysis. Patient's saliva has been received at T1, T2 and T3 for measurement of pH and buffering capacity.

DATA ANALYSES
Pearson correlation, Student Paired t-test and ANOVA for data analysis were used.

Descriptive and Inferential Statistics
Descriptive statistics show 22(44%) of male patients participated, and 28(52%) female patient participated in the study. Student Paired t-test and Pearson correlation were used to analyzing the data to compare the mean values and their association for their stages and using ANOVA within the group's comparison.  It was observed that from the Table 1, Fluoride Pre OP did not show statistical signi icance difference with Non-Fluoride Pre OP, and the mean effect difference was 0.19 only. In comparison, the Fluoride T1 with Non-Fluoride T1showedvery highly statistically signi icant difference and mean effect difference was 0.48. Furthermore, the Fluoride T2 with Non-Fluoride T2showedvery highly statistically signi icant difference and mean effect difference was 1.21. Similarly, Fluoride T3showed very highly substantial difference with Non-Fluoride T3and the mean effect was 1.72. The correlation value between Fluoride Pre OP and Non-Fluoride Pre OP was 0.89, and statistically signi icant correlated, Fluoride T1 and Non-Fluoride T1 was also significantly correlated, Fluoride T2 and Non-Fluoride T2were moderately signi icant correlated, Fluoride T3 and Non-Fluoride T3were also somewhat significant correlated.
The trajectory graph Figure 1    There is a statistical signi icance difference between Non-luoride OP and Non-luoride T1, T2, T3 as shown in Table 3. Among these statistical difference    Box and whisker plot graph Figure 5, showed the mean and standard deviation presented in their different periods among the non-luoride patterns, in the pre OP (1.97±1.05), after T1 (2.94±1.11), after T2 (4.54±1.19) and after T3 (5.96±1.23). Among the non-luoride groups, also statistically signi icant difference was found.
From Table 5, ns-Not statistical signi icance difference between Pre Salivary with Salivary T1, T2 and salivary T3 at 95% (p > 0.05). *** there is a statistically signi icant correlation between Pre Salivary with Salivary T1, Salivary T2 and Salivary T3 at 95% (p < 0.01).It was found that pre-Salivary mean value was 7.32 compared to Salivary T1 (7.28), Salivary T2 (7.33) and Salivary T3 (7.35), and the difference was insigni icant. The correlation value for pre-Salivary was 0.66 and compared with Salivary T1, T2 and T3, where the values were 0.61 for each group, and all were statistically signi icant.
From the above Table 6, all the comparison have a statistically signi icant difference; Salivary compare to non-luoride and Fluoride, we conclude that nonluoride more signi icance.

DISCUSSION
50 patients participated in the study, 100 % of the patients responded, they are following the instruction as per the dental doctor suggestions and their food habit are Non-Vegetarian, Overall OH level was very good in this study. Patient has to undergo complete oral prophylaxis before starting the treatment. Oral Hygiene instructions are also given after scaling. Standard orthodontic treatment procedure is to be carried out, and Patient has to be re-called for regular follow up visits, No patient missed the appointments between the treatment periods.
The clinical ef icacy of Fluoride and non-luoride releasing self-etching adhesives on enamel demineralization. The in luence of saliva as a predisposing factor for white spot lesions. A variety of mechanisms are involved in the anti-cariogenic effect of Fluoride. The mechanisms include reduction of demineralization, enhancement of demineraliza-tion, inhibition of pellicle and plaque formation, and inhibition of microbial growth and metabolism. Fluoride released from restorative materials may possibly inhibit caries via all of these mechanisms.
Many in vitro studies have shown that luoridereleasing restoratives can inhibit the enamel demineralization induced by acidic gels or demineralizing buffer solutions. This ability depends on the amount of Fluoride released from the materials.
In the present study, all luoride-releasing materials tested had an inhibitory effect on the development of experimental lesions around the luoridereleasing materials when compared with a nonluoridated composite. This inhibitory effect may be due to the presence of luoride ions around restorations and was dependent on the concentration of luoride ions released.
The formation of white spot lesions or enamel demineralization around ixed orthodontic attachments is a common complication during and following ixed orthodontic treatment, which mars the result of a successfully completed case. This study is a contemporary review of the risk factors, preventive methods and fate of these orthodontics scars. The importance of excellent oral hygiene practice during ixed orthodontic treatment must be explained. Preventive programs must be emphasized to all orthodontic patients. Suggestions are offered in the literature for ways to prevent this condition from manifesting itself.

CONCLUSION
Randomized clinical trial conduct as many evidences show the importance of investigating the functions of Fluoride and the in luence of saliva to treat white spot lesions among patients in India. WSL are one of the common complications of ixed orthodontic treatment. It is the responsibility of an orthodontist to minimize the risk of the Patient having decalci ication as a consequence of orthodontic treatment by educating and motivating the patients for excellent oral hygiene practice. Different regimens suggested by various authors can be prescribed to the patients to control WSL along with topical luoride application. Now Salivary compare to non-luoride and Fluoride, we conclude that nonluoride more signi icance effect compare to others.
There are several products containing Fluoride available to clinicians and their patients. Unfortunately, the evidence for the effectiveness of these products is weak. However, to date, using luoride varnish in high concentration and with regular applications is the most effective way to avoid WSL appearance. This should be implemented in close association with the control of caries risk factors. Indeed, It is still crucial to emphasize that prevention of these lesions is the furthermost desirable outcome aesthetically and also the least costly for patients. Clinicians can bene it from the study by using products containing lorid. Further, the decision-makers and the government require allocating resources and exempt tax for products containing lorid.