Unilateral Cleft Lip and Palate Surgical Protocols and Facial Growth Outcomes.

BACKGROUND

Adequate dentofacial growth is an objective of unilateral cleft lip and palate treatment. No study exists, comparing the dental arch of 5-year-old relationship after 2 treatment protocols: one with single-stage palatoplasty and another with delayed hard palate closure (DHPC). The authors hypothesized that the DHPC protocol provides better dentofacial growth.

METHODS

A single-center, single-surgeon Randomized Clinical Trial was performed to evaluate the maxillomandibular relationships in 2 groups. The intervention group (GI) underwent palatoplasty with DHPC between ages 3 and 4 years; the control group (CG) underwent complete palatoplasty between 9 and 15 months. The authors evaluated oronasal fistulae rates.The dental arch relationship was evaluated via blinded panels using the Five Year Old Index.Kappa statistics were calculated to assess reliability. Trials were statistically tested with the t test and chi-squared test.

RESULTS

Sixty-four patients constituted the study sample. The incidence of oronasal fistulae was 9.4% (GI) and 6.7% (CG). Sixty-two models with an average age of 55 months were available for analysis. Good intra- and inter-rater reliabilities (0.73-0.93 and 0.60-0.94, respectively) were obtained. Average index scores ranging from 2.04 (GI) to 2.76 (CG) were significantly different (P = 0.007). Significant between-group differences (P = 0.006) were found in scores, 1 and 2 in the GI (74%) and CG (52%). When the distributions were compared by the median, a difference was found (P = 0.024) in score, 1 between the GI (31.2%) and CG (3.3%).

CONCLUSIONS

Although the DHPC protocol yielded better outcomes relating to dentofacial growth, other protocols should be investigated and findings verified by other researchers.