Comparative assessment of facemask therapy with and without skeletal anchorage in growing Class III patients with unilateral cleft lip and palate (UCLP): A single-center, prospective randomized clinical trial.

Objective: The purpose of this study was to evaluate the maxillary protraction effect of facemask therapy with and without skeletal anchorage in growing Class III patients with unilateral cleft lip and palate (UCLP).

Materials And Methods: Thirty patients (aged 9-13 years) with UCLP having a GOSLON score 3 were selected for this prospective clinical study. The patients were allocated into two groups using computer generated random number table. Group I (facemask therapy along with two I shaped miniplates, FM + MP) and Group II (facemask mask along with tooth-anchored appliance, FM). Skeletal and dental parameters were evaluated on pre- and post-treatment lateral cephalograms and pharyngeal airway on cone-beam computed tomography systems (CBCT) for assessment of the treatment changes.

Results: Both methods proved to be effective with statistically significant improvements in skeletal and dental parameters (p < .05). Skeletal parameters (e.g., SNA, convexity-point A, ANB) with the FM + MP group showed greater change compared to those with FM group (SNA, 2.56°; convexity-point A, 1.22°; ANB, 0.35°). Significant proclination of maxillary incisors was observed in the FM group as compared to FM + MP group (U1 to NA, 5.4°; 3.37 mm). A statistically significant increase in pharyngeal airway volume was noted in both groups (p < .05).

Conclusion: While both therapies are effective in protracting the maxilla in growing patients with UCLP, the FM + MP allows for a greater skeletal correction, minimizing the dental side effects seen with FM therapy alone. Thus, FM + MP appears to be a promising adjunct in reducing the severity of Class III skeletal correction needed in patients with cleft lip and palate (CLP).