Department of Orthodontics, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, Velachery Main Road, Chennai, Tamil Nadu, 600100, India.
Plastic and Reconstructive Surgery, Sriramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu, 600116, India.
Trials. 2021 Aug 28;22(1):572. doi: 10.1186/s13063-021-05505-0.
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.
The aim of the study is to evaluate the effectiveness of pre-alveolar bone graft orthodontics for unilateral non-syndromic cleft palate patients.
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.
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.
Clinical Trials Registry - India, CTRI/2020/10/028756 . Trial prospectively registered on 29 October 2020. .
牙槽裂通常影响 75%的唇腭裂患者。虽然在牙槽骨移植前提供正畸治疗是常见做法，但目前尚无高质量研究报告这种治疗的益处。
本研究旨在评估单侧非综合征性腭裂患者牙槽骨移植前正畸的效果。
PABO 试验是一项多中心、平行、双臂、单盲随机对照试验。纳入标准包括需要进行骨移植的单侧牙槽裂患者和年龄在 8 至 13 岁之间、已萌出上颌中切牙的患者。参与者将在印度的三个中心招募。参与者将被随机分配到正畸治疗组或无正畸治疗组。两组参与者都将接受牙槽骨移植手术，并在手术后随访 6 个月。主要结局指标是通过前斜位 X 线片测量牙槽骨移植的成功率，次要结局指标包括生活质量、成本分析和牙颌结果的质量。研究结束时，将由独立的统计学家进行数据分析。
这项研究首次评估了正畸对牙槽骨移植成功率的影响。这些患者从出生到成年期需要多位专家进行多次治疗，护理负担增加，这凸显了减少不必要治疗的必要性。
印度临床试验注册处，CTRI/2020/10/028756。试验于 2020 年 10 月 29 日前瞻性注册。
