Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds (original) (raw)
Related papers
European Journal of Orthodontics, 2019
Background and trial design: The Scandcleft intercentre study evaluates the outcomes of four surgical protocols for treatment of children with unilateral cleft lip and palate (UCLP). Originally 10 cleft centres in Denmark, Finland, Norway, Sweden, and the UK participated in a set of three randomized trials of primary surgery. Three groups of centres (Trials 1, 2, and 3) tested their traditional local surgical protocols (Arms B, C, and D) against a common protocol (Arm A). Objectives: To evaluate dental arch relationships at age 8 years after four different protocols of primary surgery for UCLP. These results are secondary outcomes of the overall trial. Methods: Study models of 411 children (270 boys, 141 girls) with non-syndromic UCLP at a mean age of 8.1 (range 7.0-10.0) years were available. Dental arch relationships were analysed using the GOSLON Yardstick by a blinded panel of 11 orthodontists. To assess reliability, Kappa statistics were calculated. The trials were tested statistically with t-tests. Results: Comparisons within each trial showed no statistically significant differences in the mean 8-year index scores or their distributions between the common protocol and the local team protocol. The mean index scores were Trial 1: Arm A 3.03, Arm B 2.82, Trial 2: Arm A 2.78, Arm C 2.64, and Trial 3: Arm A 3.06, Arm D 3.08. Comparisons between the trials detected a significantly (P < 0.005) better mean index score Trial 2 Arm C than in Trial 3 Arm D. The intra-and inter-rater reliabilities were acceptable. Conclusion: The results of these three trials do not provide evidence that one surgical protocol is better than the others. Trial registration: ISRCTN29932826
European Journal of Orthodontics, 2021
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 10year index scores or their distributions within surgical trials. Comparisons between trials detected
European Journal of Orthodontics, 2019
Objectives: To assess differences in craniofacial growth at 8 years of age according to the different protocols for primary cleft surgery in the Scandcleft project. Design and setting: Prospective, randomized, controlled clinical trial (RCT) involving 10 centres, including non-syndromic Caucasians with unilateral cleft lip and palate (UCLP). In Trial 1, a common surgical method (1a) with soft palate closure at 3-4 months of age and hard palate closure at 12 months of age was tested against similar surgery but with hard palate repair at 36 months (delayed hard palate closure) (1b). In Trial 2, the common method (2a) was tested against simultaneous closure of both hard and soft palate at 1 year (2c). In Trial 3, the common method (3a) was tested against hard palate closure together with lip closure at 3 months of age and soft palate closure at 1 year of age (3d). Participants were randomly allocated by use of a dice. Operator blinding was not possible but all raters of all outcomes were blinded. Subjects and methods: The total number of participating patients at 8 years of age was 429. Lateral cephalograms (n = 408) were analysed. The cephalometric angles SNA and ANB were chosen for assessing maxillary growth for this part of the presentation. Results: Within each trial (Trial 1a/1b, Trial 2a/2c, and Trial 3a/3d), there was no difference in cephalometric values between the common and the local arm. There were no statistically significant differences in the SNA and ANB angles between the common arm in Trial 1a (mean SNA 77.8, mean ANB 2.6) and Trial 2a (mean SNA 79.8, mean ANB 3.6) and no difference between Trial 1a and Trial 3a, but a statistical difference could be seen between Trial 2a and Trial 3a (mean SNA 76.9, mean ANB 1.7). However, the confidence interval was rather large. Intra-and inter-rater reliability were within acceptable range.
Orthodontics & Craniofacial Research, 2020
ObjectiveTo compare dental arch relationships in children with unilateral cleft lip and palate (UCLP) between two surgical techniques for repair of cleft lip/palate and two ages of palate repair.Settings and SampleDental models were taken for a group of 448 subjects at a mean age of 7 years and were evaluated by means of the Goslon Yardstick. The patients studied consisted of an initial group of 673 infants with complete UCLP randomized into 8 study groups according to lip repair procedures (Millard versus Spina techniques); palate repair procedures (von Langenbeck versus Furlow techniques); and palate repair timing (early: 9 to 12 months versus late: 15‐18 months).MethodsFour surgeons performed all surgeries. Dependent variables included the following: lip repair technique, palate repair technique, age at time of palate repair and surgeon; with sex as an independent variable. The data were analysed using a general linear model (P < .05).ResultsThere were no significant differenc...
Journal of Plastic Surgery and Hand Surgery, 2017
Background Clefts of the lip and palate, occurring with an incidence of about 1 per 500 births, are among the commonest birth anomalies affecting humans. The anatomical location of the defect creates problems in feeding, speech, hearing, dental development and facial growth. Communication disability and the distorted facial appearance represent serious barriers to social integration. The success of primary surgery in the early months of life is crucial in determining outcome for the above functions, and the subsequent cost of secondary surgery and remedial care. The scientific basis of the cleft lip and palate discipline is weak since virtually no elements of treatment have been subjected to the rigours of contemporary clinical trial design (Roberts et al., 1991). Thus highly complex and varied protocols of care and a bewildering diversity of surgical technique, timing, and sequencing is practised by teams. Cleft care generally constitutes only a minor part of the clinical load of the disciplines involved-nursing, plastic surgery, maxillofacial surgery, otolaryngology, speech therapy, audiology, counselling psychology, genetics, orthodontics, dentistry. Cleft surgery is almost completely devoid of a sound evidence base. A review of 25 years of the Cleft Palate-Craniofacial Journal identified only 3 randomised control trials, and none of these involved primary surgery (Roberts et al., 1991).
Cleft Lip and Palate Surgery: An Update of Clinical Outcomes for Primary Repair
Oral and Maxillofacial Surgery Clinics of North America, 2010
The comprehensive management of cleft lip and palate has received significant attention in the surgical literature over the last half century. It is the most common congenital facial malformation in the United States and has a significant developmental, physical, and psychological impact on those with the deformity and their families. In the United States, current estimates place the prevalence of cleft lip and palate or isolated cleft lip at 16.86 per 10,000 live births (approximately 1 in 600). 1 There is significant phenotypic variation in the specific presentation of facial clefts. Care of children and adolescents with orofacial clefts needs an organized team approach to provide optimal results. 2-4 Specialists from multiple areas are needed for successful management from infancy through adolescence. These include oral and maxillofacial surgery, otolaryngology, plastic surgery, genetics and dysmorphology, speechlanguage pathology, social work, psychology, orthodontics, pediatric dentistry, prosthodontics, audiology, and nursing. 4 The specific goals of surgical care for children born with cleft lip and palate include: Normalized esthetic appearance of the lip and nose Intact primary and secondary palate Normalized speech, language, and hearing Nasal airway patency Class I occlusion with normal masticatory function Good dental and periodontal health Normal psychosocial development These goals are best achieved when surgeons with extensive training and experience in all phases of care are actively involved in the planning and treatment. 5-7 Surgical treatment must be based on the best available clinical research to avoid unfruitful, biased treatment schemes and optimize outcomes. Ideally, randomized prospective controlled trials with comparative data and appropriate outcome measures would guide one's decisions. Outcome studies pertaining to the multiple outcome measures, such as facial appearance, facial growth, occlusion, patient satisfaction, and psychosocial development, are essential. Unfortunately, this level of published
2017
Background Clefts of the lip and palate, occurring with an incidence of about 1 per 500 births, are among the commonest birth anomalies affecting humans. The anatomical location of the defect creates problems in feeding, speech, hearing, dental development and facial growth. Communication disability and the distorted facial appearance represent serious barriers to social integration. The success of primary surgery in the early months of life is crucial in determining outcome for the above functions, and the subsequent cost of secondary surgery and remedial care. The scientific basis of the cleft lip and palate discipline is weak since virtually no elements of treatment have been subjected to the rigours of contemporary clinical trial design (Roberts et al., 1991). Thus highly complex and varied protocols of care and a bewildering diversity of surgical technique, timing, and sequencing is practised by teams. Cleft care generally constitutes only a minor part of the clinical load of the disciplines involved-nursing, plastic surgery, maxillofacial surgery, otolaryngology, speech therapy, audiology, counselling psychology, genetics, orthodontics, dentistry. Cleft surgery is almost completely devoid of a sound evidence base. A review of 25 years of the Cleft Palate-Craniofacial Journal identified only 3 randomised control trials, and none of these involved primary surgery (Roberts et al., 1991).
The European Journal of …, 1997
This study examined features of dental occlusion in patients born with a unilateral cleft lip and palate (UCLP). The intention was to develop a 'Goslon type' index for 5 year old children. The Goslon ranking system was used on longitudinal study models taken at 5 and 10 years of age of the same patients. All patients had UCLP and this had been repaired using a Millard type lip repair and a Veau Wardill or Von Langenbeck palatal closure. There was good intra-examiner agreement for ascribing 5 and 10 year old models to one of five categories (excellent-very poor). Inter-examiner agreement on both sets of models was at worst moderate. Two of the examiners identified up to 93 per cent of 5 year old models which either remained in the same category or deteriorated by 10 years of age. At worse the results demonstrated 70 per cent of cases at 5 years of age remained in the same category or deteriorated by 10 years of age. Consensus agreement has produced five categories of outcome for these 5 year old models. This new index is to be subjected to further validation. This study has therefore provided, for the first time, a mechanism for assessing the results of CLP surgery earlier than indices already available.
The European Journal of Orthodontics, 2006
The aim of this study was to test the reliability of using digital photographs of study models as an alternative to the use of plaster study models in the assessment of surgical treatment outcome in 5-year-old children with unilateral cleft lip and palate (UCLP). Fifty-six dental study models available from the Managed Clinical Network for Cleft Services in Scotland (CLEFTSiS) database of patients aged 5-years with non-syndromic UCLP were employed. An experienced examiner scored the plaster study models using the modifi ed Huddart/Bodenham system. A set of digital photographs stored in the CLEFTSiS electronic patient record database of fi ve different views of the same study models were scored by three examiners to allow calculation of interexaminer reliability. The same examiners repeated the scoring 1 month later under similar conditions to determine intraexaminer reliability and minimize the infl uence of memory bias on the results. The mean kappa () value for the application of the modifi ed Huddart/Bodenham system on photographs of 5-year-old UCLP study models was 0.65 ± 0.05. The mean value for the measurement of overjet on the digital photographs was 0.68 ± 0.07. Using the interpretation suggested by Altman, good agreement for both scoring systems was found. Therefore, digital photographs of study models are a reliable alternative to measuring treatment outcome using study models of 5-year-old children with UCLP.