Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)— A study protocol for a multicentric randomised controlled trial

Background An 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. Aim The aim of t...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2021-08, Vol.22 (1), p.572-572, Article 572
Main Authors: Thiruvenkatachari, Badri, Hussain, Syed Altaf, Batra, Puneet, Vijayakumar, Charanya, Prathap. C, Manoj
Format: Article
Language:English
Subjects:
Alveolar bone graft. ABG
Birth defects
Bone-grafting
Care and treatment
Children & youth
Cleft alveolus
Cleft lip
Cleft palate
Clinical medicine
Clinical trials
Consent
Guardians
Higher education
Orthodontic appliances
Orthodontics
Patients
Pediatric research
Pre alveolar bone graft
Pregraft orthodontics
Preoperative care
SABG
Skin & tissue grafts
Study Protocol
Surgeons
Surgery
Teeth
Testing
Web portals
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Summary:Background An 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. Aim The aim of the study is to evaluate the effectiveness of pre-alveolar bone graft orthodontics for unilateral non-syndromic cleft palate patients. Method The 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. Discussion This 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 Registration Clinical Trials Registry - India, CTRI/2020/10/028756. Trial prospectively registered on 29 October 2020. . Keywords: Pre alveolar bone graft, Alveolar bone graft. ABG, Pregraft orthodontics, Cleft palate, Cleft alveolus, SABG, Cleft orthodontics
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-021-05505-0