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.

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.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: impact of maxillary dental agenesis on craniofacial growth and dental arch relationship in 8 year olds.

BACKGROUND: It is suggested that dental agenesis affects maxillary protrusion and dental arch relationship in children with unilateral cleft lip and palate (UCLP). In addition, an association between the need for orthognathic surgery and dental agenesis is reported. AIM: The aim was to study the impact of maxillary dental agenesis on craniofacial growth and dental arch relationship in 8-year-old children with UCLP. SUBJECTS AND METHODS: The sample consisted of individuals with UCLP from Scandcleft randomized trials. The participants had available data from diagnosis of maxillary dental agenesis as well as cephalometric measurements (n = 399) and GOSLON assessment (n = 408) at 8 years of age. RESULTS: A statistically significant difference was found for ANB between individuals with agenesis of two or more maxillary teeth (mean 1.52°) in comparison with those with no or only one missing maxillary tooth (mean 3.30° and 2.70°, respectively). Mean NSL/NL was lower among individuals with agenesis of two or more maxillary teeth (mean 9.90°), in comparison with individuals with no or one missing maxillary tooth (mean 11.46° and 11.45°, respectively). The number of individuals with GOSLON score 4-5 was 47.2% in the group with two or more missing maxillary teeth and 26.1% respectively 26.3% in the groups with no or one missing maxillary tooth. No statistically significant difference was found in the comparison between individuals with no agenesis or with agenesis solely of the cleft-side lateral. CONCLUSION: Maxillary dental agenesis impacts on craniofacial growth as well as dental arch relationship and should be considered in orthodontic treatment planning.

Scandcleft trial of primary surgery for unilateral cleft lip and palate: Craniofacial cephalometrics at 8 years.

BACKGROUND: The Scandcleft trial is a randomized controlled trial that includes children with unilateral cleft lip and palate where registrations are standardized and therefore provides the opportunity to describe craniofacial characteristics in a very large sample of patients. OBJECTIVES: The aim of this study was to describe craniofacial growth and morphology in a large study sample of 8-year-old children with unilateral cleft lip and palate (UCLP); before orthodontic treatment and before secondary alveolar bone grafting; and to compare the cephalometric values with age-matched non-cleft children from previous growth studies to identify the differences between untreated cleft- and non-cleft children. MATERIALS: There are 429 eight-year-old UCLP patients in the Scandcleft study group. A total of 408 lateral cephalograms with a mean age of 8.1 years were analysed. Cephalometric analyses were performed digitally. The results from three previously published growth studies on non-cleft children were used for comparison. RESULTS: Cephalometric analyses showed a large variation in craniofacial morphology among the UCLP group. In general, they present with significant maxillary retrusion and reduced intermaxillary relationships compared to the age-matched non-cleft children. In addition, the vertical jaw relationship was decreased, mainly due to decreased maxillary inclination. The upper and lower incisors were retroclined. It can be expected that these differences will increase in significance as the children age. CONCLUSION: Results from this study provide proposed norms for the young UCLP before any orthodontic treatment and can be valuable for the clinician in future treatment planning. TRIAL REGISTRATION: ISRCTN29932826.

Translation and validation of the English-language instrument Orthognathic Quality of Life Questionair into Swedish.

INTRODUCTION: In orthognathic surgery, understanding the patient's motives for treatment is a key factor for postoperative patient satisfaction and treatment success. In countries/systems where orthognathic surgery is funded by public means, patients are referred mainly due to functional problems, although studies of quality of life related changes after treatment indicate that psychosocial and aesthetic reasons might be equal or more important for the patient. There is no available validated condition specific instruments in the Swedish language for quality of life evaluation of patients with dentofacial deformities. Aims/objectives: Cross cultural translation and adaptation of the English-language instrument 'Orthognathic Quality of Life Questionnaire' (OQLQ) into Swedish. Methods: OQLQ was translated into Swedish. A total of 121 patients in four groups were recruited and the Swedish version of the OQLQ (OQLQ-S) was tested by psychometric methods. Reliability was assessed by internal consistency and test-retest reliability. Validity was evaluated by face, convergent and discriminant validity. Results/findings and conclusions: OQLQ-S is reliable and showed good construct validity and internal consistency and can be used in a Swedish speaking population as a complement to clinical variables to evaluate patients with dentofacial deformity.

Coverage, reporting degree and design of the Swedish quality registry for patients born with cleft lip and/or palate.

BACKGROUND: The objective of the Swedish cleft lip and palate (CLP) registry is to promote quality control, research and improvement of treatment, by comparison of the long-term results of surgery, orthodontics and speech from all six Swedish CLP centres. The purpose of the study was to investigate the coverage and reporting degree of the Swedish CLP registry, and to describe the design of the registry and discuss questions of reliability and validity of the data included. METHODS: All six Swedish CLP centres participate in the registry. All children in Sweden with cleft lip and/or cleft palate, born from 2009 onwards, are included in the registry. Baseline data such as cleft type (ICD-10 diagnosis), heredity, birth weight and additional deformities and/or syndromes, as well as pre-surgical treatment, are recorded at first visit. Data on surgical treatment are recorded continuously. Treatment outcome regarding dentofacial development and speech are recorded at follow-ups at 5, 10, 16 and 19 years of age. Data on dentofacial development are also recorded 1 year after orthognathic surgery. In addition, data on babbling and speech are recorded at 18 months of age. Coverage degree and reporting degree of surgery was assessed by comparison with registrations in the Swedish Central patient registry. Reporting degree of orthodontic and speech registrations at 5 years of age was assessed by comparison with registrations at baseline. RESULTS: The average coverage degree for children born 2009 to 2018 was 95.1%. For cleft-related surgeries, the average reporting degree was 92.4%. Average reporting degree of orthodontic registrations and speech registrations at age 5 years was 92 and 97.5% respectively. CONCLUSION: In order to achieve valid and reliable data in a healthcare quality registry, the degree of coverage and reporting needs to be high, the variables included should be limited and checked for reliability, and the professionals must calibrate themselves regularly. The Swedish CLP registry fulfils these requirements.

Body Mass Index and Association With Caries in School-Aged Children With Orofacial Cleft: A Case-Control Study.

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.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds.

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.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: dental anomalies in 8-year olds.

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. OBJECTIVES: The aim was to study dental anomalies at 8 years of age in children born with UCLP included in the Scandcleft randomized control trials. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ISRCTN29932826.

Do Infant Cleft Dimensions Have an Influence on Occlusal Relations? A Subgroup Analysis Within an RCT of Primary Surgery in Patients With Unilateral Cleft Lip and Palate.

AIM: To investigate whether infant cleft dimensions, in a surgical protocol with early or delayed hard palate closure, influence occlusion before orthodontics. DESIGN: Subgroup analysis within a randomized trial of primary surgery (Scandcleft). SETTING: Tertiary health care. One surgical centre. PATIENTS 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. MAIN OUTCOME MEASUREMENTS: Differences in MHB and Goslon scores among the 2 surgical groups adjusted for cleft size. RESULTS: 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 < .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). CONCLUSIONS: 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.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: occlusion in 8-year-olds according to the Modified Huddart and Bodenham index.

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. OBJECTIVES: To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP. TRIAL 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN29932826.

Validation of reported dentoalveolar relationships in the Swedish Quality Registry for Cleft Lip and Palate.

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.

Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: maxillary growth at eight years of age.

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. CONCLUSIONS: The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned. REGISTRATION: ISRCTN29932826. PROTOCOL: The protocol was not published before trial commencement.

Aesthetic perceptions and psychosocial impact of malocclusion: comparison between cleft and non-cleft patients and their parents.

Objective: To evaluate the influence of dentofacial attractiveness using the 'Psychosocial Impact of Dental Aesthetics Questionnaire' (PIDAQ), Satisfaction with Life Scale (SWLS) and Aesthetic Component (AC) of the Index of Orthodontic Treatment Need (IOTN) in patients with cleft lip/palate (CLP), and non-cleft orthodontic patients (Non-CLP) and their parents. Materials and methods: Eighty patients (aged 11-19 years) comprising 40 CLP and 40 non-CLP were administered the PIDAQ and SWLS questionnaires to be rated individually by the patients, along with IOTN-AC rated by the patients and their parents, respectively. The subjects were also sub-divided according to their age, i.e. pre-adolescent and adolescent. Results: The PIDAQ subpart scores for aesthetic concern differed between the two groups, with a significantly (P < 0.02) lower scoring for the CLP group. The adolescent CLP group scored more negatively than the pre-adolescent group in the dental self-confidence and social impact sub-parts of PIDAQ. No significant differences were observed for satisfaction with life. The parents' IOTN-AC score for both groups was significant (P < 0.05) greater than the patient's score, especially for adolescent subjects. Limitations: Non-condition specific questionnaires with restrictive sampling sizing and non-inclusion of parameters like stress coping mechanism etc. Conclusion: The parents rated the malocclusion of their child more critically than the child itself. A majority of the CLP group had a problem in identifying themselves using the IOTN-AC as no photo existed depicting a Class III or edge-to-edge malocclusion. Attitudes, especially perceptions of the aesthetics of front teeth, are crucial factors influencing patient's psychological self-concept, social confidence, and treatment need in CLP patients and non-CLP patients, having more relevance as the patient matures towards adolescence and adulthood.

A comparison of orofacial profiles in 5- and 10-year-old Swedish children with and without cleft lip and/or palate.

OBJECTIVES: The objectives of this study were to assess orofacial profiles in 5- and 10-year-old children with cleft lip and/or palate (CL/P) compared to controls and to estimate a possible association between orofacial dysfunction and caries frequency. MATERIALS AND METHODS: A total of 133 children with CL/P (77 5-year-olds and 56 10-year-olds) and 308 controls (142 5-year-olds and 166 10-year-olds) were included in the study. Orofacial function was evaluated with Nordic Orofacial Test-Screening (NOT-S), and caries were scored according to the International Caries Detection and Assessment System (ICDAS). RESULTS: The total NOT-S score was higher in children with CL/P compared to controls (mean 3.2 vs 0.9, p < 0.001). The domains frequently scored in CL/P children were speech (82%), face at rest (72%), and facial expression (58%). There was a significantly positive correlation between NOT-S scores and caries frequency. CONCLUSIONS: Children with CL/P have impaired orofacial function compared to controls. There seems to be a correlation between orofacial function and caries. CLINICAL RELEVANCE: Impaired orofacial function seen in children with CL/P can be one of many risk factors for caries development, and it is suggested to be a part of caries risk assessment.

Salivary Cortisol Rhythms in Children With Cleft Lip and/or Palate: A Case-Control Study.

OBJECTIVE: Knowledge about the stress response in children with cleft lip and/or palate (CL/P) is sparse and the association between the stress response and health-related quality of life (HRQoL) is unknown. Consequently, investigations on the influence of CL/P on the stress response alone and its association with HRQoL are of importance. The purpose was to determine whether salivary cortisol concentration in children with CL/P differs from that in children without clefts (controls) and whether there are any differences in salivary cortisol concentrations between ages, gender, and type of cleft. Furthermore, the final aim was to determine the correlation between salivary cortisol concentration and HRQoL. DESIGN: The study used a cross-sectional case-control design. PARTICIPANTS: Ninety-one 5- and 10-year-old children with CL/P and 180 age-matched controls. MAIN OUTCOME MEASURES: Salivary samples were collected on 2 mornings and 1 evening for each child. Samples were analyzed using a commercial competitive radioimmunoassay and HRQoL was assessed using the KIDSCREEN-52. RESULTS: Salivary cortisol concentrations were similar in children with CL/P and controls. There was no difference in salivary cortisol concentrations between children with different types of cleft. There was no correlation between cortisol concentration and HRQoL. CONCLUSION: Five- and 10-year-old children with corrected CL/P seemed not to be more stressed than controls, and there were no correlation to HRQoL. The HRQoL levels - were comparable to that of a European norm population.

Scandcleft randomised trials of primary surgery for unilateral cleft lip and Palate: 9. Parental report of social and emotional experiences related to their 5-year-old child's cleft diagnosis.

BACKGROUND AND AIM: Parents of children with a cleft lip and palate may be emotionally affected by the child's diagnosis. Their experiences and perceptions are important when evaluating the complexity of satisfactory treatment outcomes. The objective was to examine parents' social and emotional experiences related to their child's cleft diagnosis, and their perceptions of the child's adjustment to living with a visible difference. DESIGN: International multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: A cohort of 448 children born with a non-syndromic UCLP were included. A total of 356 parents completed the Scandcleft Parent Questionnaire. RESULTS: The majority of parents experienced practical and emotional support from family, friends, and health professionals. Nevertheless, parents had to cope with other people's reactions to the cleft, experiences that were described as ranging from hurtful to neutral and/or positive. According to parents, 39% of the children had experienced cleft-related comments and/or teasing. More than half of the parents reported specific worries related to their child's future. CONCLUSION: While the majority of the parents experienced positive support and coped well with the child's diagnosis, some parents were at risk for psychological and emotional challenges that should be identified by the cleft team. To optimise outcomes and the child's adjustment, these parents should be offered psychological support when necessary. TRIAL REGISTRATION: ISRCTN29932826.

Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 8. Assessing naso-labial appearance in 5-year-olds - a preliminary study.

BACKGROUND AND AIM: Facial appearance is one of the most relevant measures of success in cleft lip and palate treatment. The aim was to assess nasolabial appearance at 5 years of age in all children in the project. In this part of the project the local protocol for lip closure continued to be used because the primary lip and nose operations were not part of the randomisation. The great majority of the surgeons used Millard's technique together with McComb's technique for the nose. One center used Tennison-Randalls technique and in one center the centers own technique as well as nose plugs were used. METHODS: Three hundred and fifty-nine children participated in this part of the project. Standardised photos according to a specific protocol developed for the Scandcleft project were taken. Only the nasolabial area was shown, the surrounding facial features were masked. Three components were scored using a 5-point ordinal scale. A new developed Scandcleft Yardstick was used. RESULTS: The reliability of the method was tested using the weighted kappa statistics. Both the interrater and intrarater reliability scores were good to very good. There were statistically significant differences between the three trials. CONCLUSION: The Millard procedure combined with McComb technique had been used in the majority of the cases in all three trials. There were statistically significant differences between the three trials concerning upper lip, nasal form, and cleft side profile. TRIAL REGISTRATION: ISRCTN29932826.

Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 7. Occlusion in 5 year-olds according to the Huddart and Bodenham index.

BACKGROUND AND AIM: Good dentofacial development and good occlusion are main goals in the treatment of UCLP. The aim was to evaluate dental occlusion at age 5 years with the Huddart and Bodenham index after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised controlled trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, and D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Dental casts of 418 patients (272 boys, 146 girls), at the mean age of 5.1 years (range =4.7-6.9) were blindly assessed by 10 orthodontists with the original Huddart and Bodenham index. The main outcome measure was dental occlusion. RESULTS: The inter- and intra-examiner reliability was good-to-excellent (0.61-0.94; 0.66-1.0, respectively). The mean total scores (+2 to -18) varied from -5.56 (Trial 2C) to -7.21 (Trial 3D). The mean anterior scores (+2 to -6) varied from -1.66 (Trial 2C) to -2.56 (Trial 3A). The mean posterior cleft-side scores (0 to -6) varied from -3.24 (Trial 3A) to -3.82 (Trial 3D) and the mean non-cleft-side scores (0 to -6) varied from -0.60 (Trial 2C) to -1.30 (Trial 3A); however, no significant differences were found within the trials. CONCLUSION: There was no statistical evidence of a difference in occlusion between the two surgical methods in each trial. TRIAL REGISTRATION: ISRCTN29932826.

Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds.

BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised clinical trials were undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Study models of 418 patients (273 boys) at the mean age of 5.1 years (range = 4.8-7.0) were available. Dental arch relationships were assessed using the 5-year index by a blinded panel of 16 orthodontists. Kappa statistics were calculated to assess reliability. The trials were tested statistically with t- and Chi-square tests. RESULTS: Good-to-very good levels of intra- and interrater reliability were obtained (0.71-0.94 and 0.70-0.87). Comparisons within each trial showed no statistically significant differences in the mean 5-year index scores or their distributions between the common method and the local team protocol. The mean index scores varied from 2.52 (Trial 2, Arm C) to 2.94 (Trial 3, Arm D). CONCLUSION: The results of the three trials do not provide statistical evidence that one technique is better than the others. Further analysis of the possible influence of individual surgical skill and learning curve are being pursued in this dataset. TRIAL REGISTRATION: ISRCTN29932826.

A comparison of health-related quality of life in 5- and 10-year-old Swedish children with and without cleft lip and/or palate.

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.