Abstract
Background and aim: Good dentofacial development and good occlusion are main goals in the treatment of UCLP. The aim was to evaluate dental occlusion at age 5 years with the Huddart and Bodenham index after four different protocols of primary surgery for UCLP.
Design: Three parallel randomised controlled trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK.
Methods: Three different surgical procedures for primary palatal repair (Arms B, C, and D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Dental casts of 418 patients (272 boys, 146 girls), at the mean age of 5.1 years (range =4.7–6.9) were blindly assessed by 10 orthodontists with the original Huddart and Bodenham index. The main outcome measure was dental occlusion.
Results: The inter- and intra-examiner reliability was good-to-excellent (0.61–0.94; 0.66–1.0, respectively). The mean total scores (+2 to −18) varied from −5.56 (Trial 2C) to −7.21 (Trial 3D). The mean anterior scores (+2 to −6) varied from −1.66 (Trial 2C) to −2.56 (Trial 3A). The mean posterior cleft-side scores (0 to −6) varied from −3.24 (Trial 3A) to −3.82 (Trial 3D) and the mean non-cleft-side scores (0 to −6) varied from −0.60 (Trial 2C) to −1.30 (Trial 3A); however, no significant differences were found within the trials.
Conclusion: There was no statistical evidence of a difference in occlusion between the two surgical methods in each trial.
Trial registration: ISRCTN29932826.
Acknowledgements
We would like to thank professor Helen Worthington for statistical advice with this study.
Disclosure statement
The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.