Effect of presurgical orthopedics on oral-health related quality of life in Chilean children with cleft lip and palate. A pilot study.

oral-health cleft palate. A pilot study. J Oral Res 2016; 5(7): 266-270. Abstract: The aim of this pilot study was to evaluate the effect of Presurgical Orthopedics (PSO) on the oral health-related quality of life (OHR-QoL) in Children with Cleft Lip and Palate (CLP) treated in two hospitals in Chile using the Spanish version of the Child Oral Health Impact Profile (COHIP-Sp). Method: Cross-sectional study, involving 42 children with CLP (mean age 12±2.1 years; 28 men) who attended their annual checkup at the main Hospital of Valdivia and at the Hospital Fundacion Gantz in Santiago, Chile, between March and April 2016. Those who met the selection criteria were applied the COHIP-Sp scale. Based on their medical records, patients who used PSO as treatment protocol were classified as "PSO". Those who did not receive treatment with the appliance were classified as "Non-PSO". The score of the COHIP-Sp scale and its domains between the two groups was compared (t-test, p<0.05). Results: Twenty-five patients (59.5%) used PSO. COHIP-Sp score was 91.7±26.2 points in the PSO group, and 81.2±30.9 points in the Non-PSO group. There was no statistically significant difference (p=0.24). Conclusion: OHRQoL of patients with CLP treated with PSO was similar to that of patients not treated with PSO.


INTRODUCTION.
Cleft Lip and Palate (CLP) is one of the most prevalent congenital malformations. It is an alteration in the fusion of tissues that form the upper lip and palate during embryonic development. Global frequency is 1 per 1,200 live births.
In Chile its prevalence is twice the global rate with 1.8 per 1,000 live births. Therefore, since 2004 diagnosis, treatment, rehabilitation and follow-up are covered by the State. 1 Presurgical Orthopedics (PSO) in children aims to correct the abnormal position of the alveolar ridges before primary surgery in patients born with CLP. 2 PSO improves the shape of the maxillary arch, facilitating the surgical closure, feeding and speech. 3 However, some authors emphasize negative aspects of PSO, such as the complexity of its manu-facture, high economic costs, higher rates of postoperative complications, and accumulation of plaque. [3][4][5] Consequently, there is no agreement regarding the use and effectiveness of PSO in children with CLP. 6 The quality of life of children with CLP is an important and integral health indicator, observable in functional and psychosocial outcomes. 7

MATERIALS AND METHODS.
A pilot cross-sectional study was conducted between

Selection criteria and sample size.
The group of children with a history of CLP was selected by a non-probabilistic convenience sampling according to the number of medical records available at the hospitals participating in this study.
Inclusion criteria included patients with CLP between 8-15 years of age, able to read and write, and agreeing to participate voluntarily through an informed consent signed by the child's parent or guardian. Children or adolescents diagnosed with a disabling medical condition, or CLP associated with mental syndromes and disorders were excluded from the study.
Given the nature of the pilot study, a minimum of 25 patients were estimated for the evaluation, considering an average COHIP-Sp scale of 98.8±18.3, 14 with a difference of 13.3 points between patients who used and did not use PSO, 15 and a statistical power of 80%.

Groups.
Children who used presurgical orthopedic appliances according to protocol treatment of the participating hospitals were classified as "PSO". Children treated at the same hospitals but without using orthopedic appliances were classified as "Non-PSO".  were compared using STATA v10.0 (STATACorp®, USA).

RESULTS.
Forty-two patients with an average age of 12±2. There was no statistically significant difference between both groups (p=0.24). The comparative analysis of the scores of the domains of the COHIP-Sp scale is presented in Table 2.

DISCUSSION.
OHRQoL of children with CLP treated with PSO at two Chilean hospitals showed similar levels to those of children not treated with PSO. Similarly, in various domains of the scale there were no statistically significant differences between the two groups. These results are consistent with previous studies that have not found a positive and significant effect of PSO on aspects such speech and language development in children with CLP. 3 Consequently, there are no studies providing a high level of evidence to support the use of PSO in children. 16 In addition, regarding facial aesthetics, it is reported that the transverse dental arch relationships do not differ in children aged 9 to 12 years treated or not treated with PSO. 17 This finding is relevant because aesthetics and sequelae in language seem to be the most important factors affecting the quality of life in children with oral clefts, especially from 8 years onwards, when the acceptance by peers becomes more critical. 18 The highest proportion of the sample consisted of male subjects with left CLP. These data are similar to those reported in Dutch and Colombian populations. 19 Although in this study the participants were volunteers contacted by convenience while attending their annual checkups, the number and characteristics of participants are similar to those reported in Chile. 1,14 In the present study it was not possible to establish a significant statistical association between OHRQoL and the use of POS. This is consistent with a systematic review by Bessell et al. 20 This pilot study presents data confirming previous reports, which may prove useful to make researchers and clinicians assess the benefits of using POS in children. This study agrees with the findings of Papadopoulos et al. 21 , who expose the lack of evidence on the short and long term effectiveness of POS in the treatment of patients with CLP.
Within the limitations of this study, it is possible to mention that modifying or confounding variables of the POS-OHRQoL relationship were not analyzed, such as the age of children, the length of time patients used POS, attendance to the annual checkups assessed by the multidisciplinary team, as well as the socio-cultural environment of the patients. In addition, a convenience sample was used and some medical records were incomplete and/or illegible, which may have negatively affected the quality of the data collected.
Longitudinal studies should be conducted to assess the impact of POS on aesthetic and functional aspects in adolescent and adult patients with CLP.

CONCLUSION.
OHRQoL of patients with CLP treated with POS was similar to the one shown by patients not treated with POS.

ACKNOWLEDGMENTS.
The authors would like to thank the management and staff at the main Hospital of Valdivia and Hospital Foundacion Gantz for allowing access to checkups and patient care. We thank each child and their family for their contribution to this work. This research is based in part on the requirements of Maysa Brandt Silva y Francisca Klett Vargas for obtaining their DDS degree at the School of Dentistry at Universidad Austral de Chile, in September 2016.