Abstract
BackgroundAn alveolar cleft commonly affects 75% of cleft lip and palate patients. While it is common practice to provide a course of orthodontic treatment before alveolar bone grafting, there are no previous high-quality studies reporting on the benefits of this type of treatment.AimThe aim of the study is to evaluate the effectiveness of pre-alveolar bone graft orthodontics for unilateral non-syndromic cleft palate patients.MethodThe PABO trial is a multicentric, parallel, two-arm, single-blinded randomised controlled trial. The inclusion criteria include unilateral cleft alveolus patients requiring bone graft and between the age group of 8 and 13 years with erupted upper central incisors. Participants will be recruited at three centres across India. Participants will be randomised to orthodontic treatment or no orthodontic treatment group. Both groups of participants will have alveolar bone graft surgery and will be followed up for 6 months after surgery. The primary outcome will be the success of the alveolar bone graft measured by anterior oblique radiograph and secondary outcomes include quality of life, cost analysis and quality of the dento-occlusal outcome. Data analysis will be carried out by an independent statistician at the end of the study.DiscussionThis study is the first to evaluate the effect of orthodontics on alveolar bone graft success. The increased burden of care for these patients with multiple treatments required from multiple specialists from birth to adult life highlights the need for reducing unnecessary treatment provision.Trial RegistrationClinical Trials Registry – India, CTRI/2020/10/028756. Trial prospectively registered on 29 October 2020..
Highlights
This study is the first to evaluate the effect of orthodontics on alveolar bone graft success
In a previous study looking at the burden of orofacial clefting (OFC), it has been reported that a total of 79,430 cleft patients had unmet treatment needs which accounted for 18.76% of the total Indian cleft population [4]
The Prealveolar bone graft Orthodontics (PABO) study has the goal of reducing the burden of care for patients with cleft palate
Summary
The PABO study has the goal of reducing the burden of care for patients with cleft palate These children undergo treatment from different specialists at various timepoints in their life. Orthodontic treatment is a lengthy course of treatment and to add this in addition to other orthodontic treatments in the later part of their lives along with the already increased burden of care from other problems must be justified This early orthodontic treatment is mainly carried out to make the alveolar bone graft surgery less complicated and to a minimal extent, align the front teeth for aesthetic reasons. If this can be avoided with no compromise on the quality of overall outcome at the of surgery will be a huge benefit for these patients.
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