A Randomised Trial of Pre-Alveolar Bonegraft Orthodontics for Patients With Non-Syndromic Unilateral Cleft lip and Palate (PABO Study)
In brief
Pre-graft orthodontics did not raise bone-graft success, about 91% in both groups
In a randomized trial of 72 patients aged 8 to 13 with unilateral cleft lip and palate, bone-graft success at six months was about 91% with pre-graft orthodontics and without it. The groups also showed no significant differences in other measured outcomes, supporting a re-evaluation of routine pre-graft treatment; the small trial leaves room for uncertainty.
- Journal
- The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association (Q1)
- Published
- 29 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Badri Thiruvenkatachari, Manoj Prathap, Karthika Nambiar, Subhiksha Chakkaravarthi, Syed Altaf Hussain, Charanya Vijayakumar, et al.
- PMID
- 42811425
- DOI
- 10.1177/10556656261486113
Why clinicians should know about it
- Picked for Otorhinolaryngology (top studies of the week, 4 October 2026): Orthodontic pre‑graft trial lacks ENT surgical relevance
- Picked for Plastic and Reconstructive Surgery (top studies of the week, 4 October 2026): Pre‑alveolar bone‑graft orthodontics in cleft lip/palate, orthodontic focus
Abstract
BackgroundPre-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.ObjectiveTo evaluate the effectiveness of pre-surgical orthodontics on the success of ABG in patients with UCLP.DesignSingle blinded, parallel group multi-centric randomised controlled trial.SettingSecondary and tertiary care hospitals.Participants and interventionSeventy-two participants between the age group of 8 and 13 were randomly assigned into either the orthodontic treatment group (OTG) or no orthodontic group.OutcomesThe 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.ResultsAt 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 CPQ8-10 (U = 89.0, Z = -0.393, P = 0.694). Per-protocol analysis also showed no statistically significant differences for any of the outcomes measured.ConclusionThere 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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.