A Randomised Trial of Pre-Alveolar Bonegraft Orthodontics for Patients With Non-Syndromic Unilateral Cleft lip and Palate (PABO Study)

Background Pre-surgical orthodontic intervention is widely used to improve surgical access and facilitate alveolar bone grafting (ABG) for patients with unilateral complete cleft lip and palate (UCLP). However, robust evidence supporting its effectiveness remains limited. Objective To evaluate the effectiveness of pre-surgical orthodontics on the success of ABG in patients with UCLP. Design Single blinded, parallel group multi-centric randomised controlled trial. Setting Secondary and tertiary care hospitals. Participants and intervention Seventy-two participants between the age group of 8 and 13 were randomly assigned into either the orthodontic treatment group (OTG) or no orthodontic group. Outcomes The primary outcome was ABG success assessed using the Bergland index from oblique occlusal radiographs taken at 6 months post-surgery. Secondary outcomes were GOSLON index, dentofacial growth, quality of life and harms. Results At 6 months post ABG, the success for the orthodontic group was 91.43%, and for the no treatment control group was 91.89% for imputed data (OR 1.06, 95% CI 0.19 to 5.65, P = 0.943). There was no significant difference between the treatment and control group for GOSLON scores (OR 0.68, 95% CI 0.26 to 1.77, P = 0.437), skeletal growth (MD 0.23, 95% CI −2.08 to 2.55, P = 0.839) or Child Perceptions Questionnaire CPQ 8-10 (U = 89.0, Z = –0.393, P = 0.694). Per-protocol analysis also showed no statistically significant differences for any of the outcomes measured. Conclusion There was no statistically significant difference between the OTG and the no orthodontic control group in the success of ABG surgery. The findings suggest that the routine use of pre-graft orthodontics warrants re-evaluation.