A novel technique predicting velopharyngeal insufficiency risk in newborns following primary cleft repair. A randomized clinical trial comparing buccinator flap and Bardach two-flap palatoplasty

The study aimed to assess the efficacy of buccinator myomucosal flap (BMF) compared to Bardach two-flap use in primary cleft palatoplasty on palatal length and fistulation rate. Palatal length in relation to the pharynx is a critical factor regarding velopharyngeal function. The goal was to predict the risk of velopharyngeal insufficiency by comparing the potential of two different techniques in lengthening the palate and to decrease the fistulation rate. A total of 46 patients with complete wide cleft palate were randomly divided into two equal groups: a study group, in which the cleft palate defect was repaired by BMF; and a control group, in which patients' clefts were repaired by Bardach (two-flap) palatoplasty during primary repair. All patients were evaluated at 1-, 3- and 6-month intervals to detect the fistulation rate and to measure the palatal length by taking impressions, pouring casts to measure the palatal length from anterior reference point (incisive foramen) to the posterior reference point(uvula) and calculating the change of palatal length. There was a significant increase in the palatal length measurements in the study (BMF) group (immediate postoperatively and at 3 and 6 months) compared to the control group (p < 0.001). Regarding the fistulation rate, there was no statistically significant difference (p = 0.346). The use of the buccinator flap during primary repair of cleft palate decreased the fistulation rate.