Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 7. Occlusion in 5 year-olds according to the Huddart and Bodenham index.

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.