Background: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate, and randomised trials have only rarely been performed. The Scandcleft Project consists of three trials commenced in 1997 involving ten centres in Denmark, Finland, Norway, Sweden, and the UK. Three groups of centres tested a newly-defined common technique for palatal repair (Arm A) against their local protocols (Arms B, C, D). Arm A was familiar to most of the surgeons in Trial 1, but not to the surgeons in the other Trials.
Aim: To evaluate surgical events and complications of the 448 (293 boys, 155 girls) patients with complete unilateral cleft lip and palate (UCLP) enrolled in the three trials.
Method: The three trials were carried out in parallel in adherence with a fully developed, ethically approved protocol. Operative time, bleeding, complications, and major dehiscence during and after both primary surgeries were recorded by the surgeon. Rates of fistula and surgery for velopharyngeal incompetence (VPI) were assessed until the youngest patient of the study had reached the age of 9 years. Pearson Chi-square statistical analysis was used to compare the outcomes.
Results: No significant differences in bleeding, infection, anaesthetic complications or length of hospital stay between the different arms were found for Trial 1. However, in Trials 2 and 3 there were more airway problems in Arm A than with the traditional local protocols (Arms C or D). In Trial 3 fistula and VPI surgery rates were also higher in Arm A.
Conclusions: The results do not provide statistical evidence that any technique is better than others, but indicate that surgery was more problematic for surgeons who were still gaining experience with an unfamiliar surgical protocol.
Trial Registration: ISRCTN29932826.
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http://dx.doi.org/10.1080/2000656X.2016.1254646 | DOI Listing |
Cleft Palate Craniofac J
January 2025
Plastic and Oral Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.
Objective: The purpose of this study was to quantify analgesic use following alveolar cleft bone grafting (ABG) utilizing a posterior iliac crest (PIC) donor site.
Design: This is a prospective cohort study of consecutive patients that underwent ABG with PIC in a 10 month period from November 2022 to September 2023.
Setting: Tertiary care free-standing pediatric hospital.
J Plast Reconstr Aesthet Surg
January 2025
Research & Evidence (RF&E), Vasant Kunj, New Delhi, India. Electronic address:
Am J Orthod Dentofacial Orthop
January 2025
Department of Orthodontics, Faculty of Dentistry, Hacettepe University, Ankara, Turkey. Electronic address:
Introduction: The objective of this study was to evaluate the effects of the miniplate application sites in the maxilla and the applied force vector changes during skeletally supported facemask application in adolescent patients with unilateral cleft lip and palate (UCLP) using finite element model (FEM) analysis.
Methods: A FEM was obtained from a cone-beam computed tomography image of a 12-year-old female patient with UCLP. Miniplates were placed on 3 different sites of the maxilla; 500 g of advancement force was applied bilaterally, parallel (0°), and downward (-30°) to the occlusal plane.
Trials
January 2025
INSERM, Regenerative Medicine and Skeleton, RMeS, CHU Nantes, Nantes Université, UMR 1229, Nantes, 44000, France.
Background: Cleft lip and/or palate is the most common congenital orofacial deformity, affecting 1/800 births. A thorough review of the literature has shown that children with cleft have poorer oral hygiene and dental health than other children, with higher levels of caries in both temporary and permanent teeth and poorer periodontal health. Cleft patients are treated by a multidisciplinary team that aims to provide comprehensive care from pre- or post-natal diagnosis to early adulthood and the end of growth.
View Article and Find Full Text PDFJ Craniofac Surg
October 2024
Health of Science Faculty School of Human Medicine, Peruvian University Union (UpeU).
Background: Unilateral cleft lip secondary nasal deformities are common and require surgical correction frequently. The nasal dome on the cleft side is depressed, and the nasal ala is in an extended and flattened position compared with the noncleft side. In addition, the nasal septum is deviated into the cleft nostril.
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