Primary Surgical Protocol and Early Maxillary Growth in Unilateral Cleft Lip and Palate: Talmant Versus Malek—A Retrospective Comparative Study

Objective To compare early maxillary growth at age 4 in non-syndromic complete unilateral cleft lip and palate (UCLP) between 2 sequential primary surgical protocols. Design Retrospective before-after comparative cohort study of 2 successive treatment periods. Setting Single tertiary cleft center, 1990 to 2019. Patients Fifty-four patients with non-syndromic complete UCLP (21 Malek, 33 Talmant). Interventions Malek protocol (veloplasty at 3 months, cheilo-palatoplasty at 6 months) versus Talmant protocol (cheilo-veloplasty at 6 months, delayed palatoplasty at 18 months). Main Outcome Measures GOSLON (Great Ormond Street, London, and Oslo) Yardstick score (primary); overjet and intercanine distance (secondary), assessed on dental casts at age 4. Results Groups did not differ in sex, cleft side, or lateral incisor status. GOSLON scores were better in the Talmant group (median 2 [interquartile range (IQR), 1-3] versus 3[3-4]; Mann-Whitney P < .001). Positive overjet was more frequent with Talmant (82% vs 33%; Fisher P < .001; adjusted odds ratio (OR) = 9.10; 95% confidence interval (CI): 2.53-38.7). Intercanine distance did not differ (adjusted β = 1.7 mm; 95% CI: −0.01-3.3; P = .051, inconclusive). Conclusions Delayed hard-palate closure was associated with better dental arch relationships and more frequent positive overjet at age 4. Because the protocols were used in successive periods and because the Talmant protocol was performed by a single surgeon, neither a period effect nor a surgeon effect can be separated from a protocol effect. The primary outcome was scored by a single non-blinded examiner without reliability testing; these findings are therefore hypothesis-generating and represent an association, not evidence of causation.