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. Students t-test, Pearsons 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.

OBJECTIVE: Data on the association between body mass index (BMI) and dental caries in children with orofacial clefts are sparse. Therefore, studies on the impact of BMI on caries frequency in children with cleft lip and/or palate (CL/P) are of importance. The aim of the current study was to investigate the association between BMI and frequency of dental caries in children with and without CL/P. Height, weight, and BMI in children with CL/P were also compared to controls.

DESIGN: This study used a cross-sectional case-control design.

PARTICIPANTS: One hundred and thirty-nine 5- and 10-year-old children with CL/P and 299 age-matched controls.

MAIN OUTCOME MEASURES: Caries was recorded according to the International Caries Detection and Assessment System. Height and weight were recorded, and BMI was calculated as weight/height².

RESULTS: There was no correlation between BMI and caries frequency. Weight, height, and BMI were significantly lower in all children with CL/P compared to controls. After adjustment for international adoption, only BMI was significantly lower in CL/P children compared to controls. Non-adopted children with CL/P were significantly heavier and longer than adopted children with CL/P.

CONCLUSIONS: Five- and 10-year-old children with corrected CL/P seemed to have a lower BMI than controls, but there was no association between BMI and caries frequency. Internationally adopted children with CL/P were lighter and shorter than non-adopted CL/P children and controls.

Aim: To investigate whether infant cleft dimensions, in a surgical protocol with early or delayed hard palate closure, influence occlusion before orthodontics.less thanbr /greater thanDesign: Subgroup analysis within a randomized trial of primary surgery (Scandcleft).less thanbr /greater thanSetting: Tertiary health care. One surgical centre.less thanbr /greater thanPatients and Methods: A total of 122 unilateral cleft lip and palate infants received primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure at age 12 versus 36 months. A novel 3D analysis of cleft size and morphology was performed on digitized presurgical models. Occlusion was scored on 8-year models using the modified Huddarth-Bodenham (MHB) Index and the Goslon Yardstick.less thanbr /greater thanMain Outcome Measurements: Differences in MHB and Goslon scores among the 2 surgical groups adjusted for cleft size.less thanbr /greater thanResults: The crude analysis showed no difference between the 2 surgical groups in Goslon scores but a better MHB (P = .006) for the group who received delayed hard palate closure. When adjusting for the ratio between cleft surface and palatal surface (3D Infant Cleft Severity Ratio) and for posterior cleft dimensions at tuberosity level, the delayed hard palate closure group received 3.65 points better for MHB (confidence interval: 1.81; 5.48; P less than .001) and showed a trend for reduced risk of receiving a Goslon of 4 or 5 (P = .052). For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group (P = .033).less thanbr /greater thanConclusions: Seen from an orthodontic perspective, when the soft palate is closed first, and the cleft is large, the timing of hard palate closure should be planned in relation to posterior cleft size.

Background: Children born with unilateral cleft lip and palate (UCLP) are reported to display several dental anomalies including agenesis, supernumeraries, as well as variations in dental size, shape, and path of eruption. The extensive sample of individuals with UCLP included in the Scandcleft randomized control trials offers the opportunity to study more rare conditions, which is seldom possible with limited samples.less thanbr /greater thanObjectives: The aim was to study dental anomalies at 8 years of age in children born with UCLP included in the Scandcleft randomized control trials.less thanbr /greater thanMethods: Panoramic and intraoral radiographs from 425 individuals (279 males and 146 females) with a mean age of 8.1 years were assessed by four orthodontists regarding dental anomalies.less thanbr /greater thanResults: Agenesis was found in 52.5 per cent and supernumerary teeth in 16.9 per cent of the participants. The cleft lateral was missing in 43.8 per cent and was found peg shaped in 44.7 per cent. The distribution of ectopic eruption was 14.6 per cent, mainly affecting maxillary first molars, while transposition was found in 3.4 per cent of the individuals. In addition, infraocclusion of one or several primary molars was registered in 7.2 per cent of the participants.less thanbr /greater thanConclusion: We conclude that 8-year-old children born with UCLP display multiple dental anomalies. The Scandcleft sample allowed rarely studied conditions such as infraocclusion of primary molars and transposition to be studied in children born with UCLP.less thanbr /greater thanTrial Registration: ISRCTN29932826.less thanbr /greater than (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

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).less thanbr /greater thanObjectives: 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.less thanbr /greater thanMethods: 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.less thanbr /greater thanResults: 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 less than 0.005) better mean index score Trial 2 Arm C than in Trial 3 Arm D. The intra- and inter-rater reliabilities were acceptable.less thanbr /greater thanConclusion: The results of these three trials do not provide evidence that one surgical protocol is better than the others.less thanbr /greater thanTrial Registration: ISRCTN29932826.less thanbr /greater than (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

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.less thanbr /greater thanDesign 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.less thanbr /greater thanSubjects 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.less thanbr /greater thanResults: 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.less thanbr /greater thanConclusions: The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned.less thanbr /greater thanRegistration: ISRCTN29932826.less thanbr /greater thanProtocol: The protocol was not published before trial commencement.less thanbr /greater than (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The Scandcleft international multicenter study is a prospective clinical trial of the long-term outcome after four different surgical protocols for palatal closure in patients born with unilateral cleft lip and palate (UCLP). This paper is one of a series of follow-up studies in 8-year olds.less thanbr /greater thanObjectives: To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP.less thanbr /greater thanTrial Design: Ten cleft centres in five countries tested three different surgical procedures for primary palatal repair in three parallel trials (Arms B, C, and D) against a common procedure (Arm A).less thanbr /greater thanMethods: Initially 448 children born with non-syndromic UCLP were included in the project. At 8 years of age, 428 children remained in the study. Dental casts of 411 patients (270 boys, 141 girls), mean age 8.1 years (range 7.0-10.0) were taken. The casts were blindly assessed with the Modified Huddart and Bodenham (MHB) index by four orthodontists. The main outcome measures were anterior (+2 to -6) and posterior (0 to -8) mean scores. Comparisons were made with previous data in 5-year-olds.less thanbr /greater thanResults: The inter- and intra-examiner reliability was good to excellent (0.75-0.90; 0.73-0.97), respectively. The mean total scores varied from -7.09 (Trial 2C) to -10.13 (Trial 3D). The mean anterior scores varied from -1.75 (Trial 2C) to -3.18 (Trial 1A). The mean posterior cleft-side scores varied from -4.32 (Trial 1B) to -5.21 (Trial 3D) and the mean non-cleft-side scores varied from -0.88 (Trial 2C) to -2.40 (Trial 3A). No significant differences were found within the trials. A significant difference was found between Trials 2 and 3 (Arm C/D) for the total score (P = 0.004).less thanbr /greater thanConclusions: There was no evidence of clinically significant differences in occlusion between the two surgical methods in each trial or between the trials. All mean scores showed more negative values in 8-year-olds compared with previously reported values in 5-year-olds.less thanbr /greater thanTrial Registration: ISRCTN29932826.less thanbr /greater than (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

OBJECTIVES: The present study validated data that had been reported to the Swedish Quality Registry for Cleft Lip and Palate (CLP) under new requirements from 2016, when use of the 5-year-old (5YO) and the Modified Huddart and Bodenham (MHB) indices for rating occlusion in children born with unilateral CLP (UCLP) was introduced.

MATERIALS AND METHODS: The sample included blinded study casts (n = 97) and photos (n = 4) of 5-year-old children who had been born with UCLP in 2009-2011 and were enrolled at one of six cleft centres in Sweden. Fourteen orthodontists from the centres assessed the patients (n = 101) using the 5YO and the MHB indices. Median 5YO and MHB scores of the 14 assessments were compared with original registry data (n = 61). Each centre devised code keys to protect the identities of their patients in the registry.

RESULTS: Interrater agreement among the 14 orthodontists was good for the 5YO index (quadratic-weighted kappa: 0.72-0.92) and the MHB index (intraclass correlation coefficient: 0.991-0.994). Comparisons of median 5YOs for each identifiable child with their registry data (n = 61) found total agreement for 70.5 per cent. Comparisons between median MHBs and registry data showed very good or good agreement in 93.4 per cent of the cases.

LIMITATIONS: Two teams lost their code keys, which reduced the sample to 61 patients.

CONCLUSIONS: The dentoalveolar outcome data in the CLP registry was trustworthy. There was good agreement among the Swedish cleft teams assessing the 5YO and MHB indices in children born with UCLP at age 5 years.

To compare the salivary microbial profile in children with oral clefts to matched non-cleft controls in a cross-sectional study.

Background The current understanding on health-related quality of life (HRQoL) in young Swedish children with cleft lip and/or palate (CL/P) is sparse, and therefore, research on impact of CL/P on HRQoL in children is needed.

Aims To investigate HRQoL in 5- and 10-year-old Swedish children with CL/P in comparison with non-cleft controls. Also to analyse whether there were any differences in HRQoL between children with cleft lip (with or without cleft palate, CL ± P) and cleft palate only (CP) and/or gender differences. Design A total of 137 children with CL/P and 305 non-cleft controls participated. HRQoL was measured with KIDSCREEN-52.

Results All children in the study exhibited HRQoL within or above the age-matched reference interval of the method with similar results in both groups; however, in the dimension ‘social support and peers’, the 10-year-old children with CL/P perceived lower HRQoL than the non-cleft controls, but it did not reach statistical significance. Type of cleft or gender did not influence HRQoL.

Conclusions Both 5- and 10-year-old Swedish children with CL/P had HRQoL in the normal reference interval. Their general life situations were well adjusted to their clefts, but the older children with CL/P felt more excluded and less supported by peers.