Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: comparison of dental arch relationships and dental indices at 5, 8, and 10 years

Abstract

Summary Background and trial design The Scandcleft intercentre study evaluates the outcomes of four surgical protocols (common method Arm A, and methods B, C, and D) for treatment of children with unilateral cleft lip and palate (UCLP) in a set of three randomized trials of primary surgery (Trials 1, 2, and 3). Objectives To evaluate and compare dental arch relationships of 5-, 8-, and 10-year-old children with UCLP after four different protocols of primary surgery and to compare three dental indices. The results are secondary outcomes of the overall trial. Methods Study models taken at the ages of 5 (n = 418), 8 (n = 411), and 10 years (n = 410) were analysed by a blinded panel of orthodontists using the Eurocran index, the 5-year-olds’ (5YO) index, and the GOSLON Yardstick. Student’s t-test, Pearson’s correlation, chi-square test, and kappa statistics were used in statistical analyses. Results The reliability of the dental indices varied between moderate and very good, and those of the Eurocran palatal index varied between fair and very good. Significant correlations existed between the dental indices at all ages. No differences were found in the mean 5-, 8-, and 10-year index scores or their distributions within surgical trials. Comparisons between trials detected significantly better mean index scores in Trial 2 Arm C (at all ages) and in Trial 1 Arm B (at 5 and 10 years of age) than in Trial 3 Arm D. The mean Eurocran dental index scores of the total material at 5, 8, and 10 years of age were 2.50, 2.60, and 2.26, and those of the 5YO index and GOSLON Yardstick were 2.77, 2.90, and 2.54, respectively. At age 10 years, 75.8% of the patients had had orthodontic treatment. Conclusions The results of these three trials do not provide evidence that one surgical method is superior to the others. The reliabilities of the dental indices were acceptable, and significant correlations existed between the indices at all ages. The reliability of the Eurocran palatal index was questionable. Trial registration ISRCTN29932826.

Speech Symptoms of Velopharyngeal Insufficiency and the Incidence of Secondary Speech Surgery in 10-Year-Old Children With Unilateral Cleft Lip and Palate: Comparison of 2 Randomized Surgical Methods for Primary Palatal Surgery

“…However, no significant differences between dental arch relationships between Arms A and C have been found in Trial 1 at 5, 8, and 10 years. 39…”

LncRNA-NONMMUT100923.1 regulates mouse embryonic palatal shelf adhesion by sponging miR-200a-3p to modulate medial epithelial cell desmosome junction during palatogenesis

“…The disease causes great mental and financial stress to the children and their families [ 24 ]. At present, there is limited methods for prenatal prevention and the outcome of surgical treatment is not satisfied [ 25 , 26 ]. Studies have shown that LncRNA is widely involved in cell differentiation, metabolism, and proliferation, and closely related to a variety of diseases [ 19 , [27] , [28] , [29] ].…”

A Cross-Sectional Study of the Dental Arch Relationship and Palatal Morphology after Cleft Surgery in Italian Children with Unilateral Cleft and Lip Palate

“…A recent randomised controlled study did not find any statistically significant difference in DAR outcomes between EPR with the hard and soft palates repaired at 3–4 months and DPR in which the hard palate closure was postponed to 12 or 36 months. No data were reported for the PM because the authors did not find the parameter to be acceptably reliable [ 42 ]. Stein et al observed a similar palatal height but a smaller transverse distance in the upper anterior arch following EPR which tended to compensate at the ages of 15 to 18 years, reaching values comparable to DPR [ 43 ].…”