A randomized controlled trial comparing two techniques for unilateral cleft lip and palate: Growth and speech outcomes during mixed dentition

Abstract

Objective: To study the growth and speech outcomes in children who were operated on for unilateral cleft lip and palate (UCLP) by a single surgeon using two different treatment protocols.

Material and methods: A total of 200 consecutive patients with nonsyndromic UCLP were randomly allocated to two different treatment protocols. Of the 200 patients, 179 completed the protocol. However, only 85 patients presented for follow-up during the mixed dentition period (7-10 years of age). The following treatment protocol was followed. Protocol 1 consisted of the vomer flap (VF), whereby patients underwent primary lip nose repair and vomer flap for hard palate single-layer closure, followed by soft palate repair 6 months later; Protocol 2 consisted of the two-flap technique (TF), whereby the cleft palate (CP) was repaired by two-flap technique after primary lip and nose repair. GOSLON Yardstick scores for dental arch relation, and speech outcomes based on universal reporting parameters, were noted.

Results: A total of 40 patients in the VF group and 45 in the TF group completed the treatment protocols. The GOSLON scores showed marginally better outcomes in the VF group compared to the TF group. Statistically significant differences were found only in two speech parameters, with better outcomes in the TF group.

Conclusions: Our results showed marginally better growth outcome in the VF group compared to the TF group. However, the speech outcomes were better in the TF group.

Keywords: Growth; Mixed dentition; Speech outcomes; Two-flap technique; Vomer flap.