Prevalence and Factors Associated with Behavioral Problems in 5-Year-Old Children Born with Cleft Lip and/or Palate from the Cleft Collective.

OBJECTIVES: To determine the UK prevalence of behavioral problems in 5-year-old children born with isolated or syndromic cleft lip and/or palate (CL/P) compared to the general population and identify potentially associated factors. DESIGN: Observational study using questionnaire data from the Cleft Collective 5-Year-Old Cohort study and three general population samples. MAIN OUTCOME MEASURE: The Strengths and Difficulties Questionnaire (SDQ). PARTICIPANTS: Mothers of children (age: 4.9-6.8 years) born with CL/P (n = 325). UK general population cohorts for SDQ scores were: Millennium Cohort Study (MCS) (n = 12 511), Office of National Statistics (ONS) normative school-age SDQ data (n = 5855), and Avon Longitudinal Study of Parents and Children (ALSPAC) (n = 9386). RESULTS: By maternal report, 14.2% of children born with CL/P were above clinical cut-off for behavioral problems, which was more likely than in general population samples: 7.5% of MCS (OR = 2.05 [1.49-2.82], P < 0.001), 9.8% of ONS (OR = 1.52 [1.10-2.09], P = 0.008), and 6.6% of ALSPAC (OR = 2.34 [1.70-3.24], P < 0.001). Children in the Cleft Collective had higher odds for hyperactivity, emotional and peer problems, and less prosocial behaviors. Maternal stress, lower maternal health-related quality of life and family functioning, receiving government income support, and maternal smoking showed evidence of association (OR range: 4.41-10.13) with behavioral problems, along with maternal relationship status, younger age, and lower education (OR range: 2.34-3.73). CONCLUSIONS: Findings suggest elevated levels of behavioral problems in children born with CL/P compared to the general population with several associated maternal factors similar to the general population.

Surgical sequence, timing and volume, and variation in dento-facial outcome, speech and secondary surgery in children with unilateral cleft lip and palate: The Cleft Care UK Study.

OBJECTIVES: To estimate both the association of surgical variables in complete unilateral cleft lip and palate (cUCLP) in the UK with outcomes at age 5 years, and the association of secondary speech surgery, volume of surgery, and surgeon with the same outcomes. SETTING AND SAMPLE POPULATION: The Cleft Care UK study, a cross-sectional study of 268 5-year-olds, born from 2005 to 2007, with cUCLP. MATERIALS AND METHODS: Information on surgical variables was extracted from a standardized questionnaire. Dento-facial outcomes were derived from dental study casts of dental arch relationships. Three speech outcomes - intelligibility, structure and articulation - were derived using the Cleft Audit Protocol for Speech-Augmented tool. RESULTS: Surgical and outcome data were available for 211 (79%) children from all cleft centres in the UK. Later soft palate surgery was associated with a 17% increased chance of a poor intelligibility score (P = .02), and high volume surgery with a 249% increased chance of a good articulation score (P = .01). There were no between surgeon effects identified. No association between the surgical variables examined and dento-facial outcome, or secondary speech surgery by the age of 5 years were found. CONCLUSION: This study found associations between surgical variables and speech outcomes at 5 years of age, but not between surgical variables and dento-facial outcome, nor between surgical variables and secondary speech surgery. High surgical volume should be maintained, and any changes towards later surgery monitored for changes in speech outcome.

Maternal Cigarette Smoking and Cleft Lip and Palate: A Systematic Review and Meta-Analysis.

A systematic review and meta-analysis to determine the association between active maternal smoking and cleft lip and palate etiology.Medline, Embase, Web of Science and the Cochrane Library from inception to November, 2020.Observational studies of cigarette smoking habits in pregnant women. Outcomes included cleft lip and/or palate, cleft lip ± palate and cleft palate only.Publication bias analyses were performed and the Newcastle Ottawa scales were used to assess study quality. Fixed or random effect models were used in the meta-analysis, dependent on risk of statistical heterogeneity.Forty-five studies were eligible for inclusion of which 11 were cohort and 34 were case-control studies. Sixteen studies were of sufficient standard for inclusion in the meta-analysis. The summary odds ratio for the association between smoking and cleft lip and/or palate was 1.42 (95%CI 1.27-1.59) with a population attributable fraction of 4% (95%CI 3%-5%). There was limited evidence to show a dose-response effect of smoking.This review reports a moderate association between maternal smoking and orofacial cleft but the overall quality of the conventional observational studies included was poor. There is a need for high quality and novel research strategies to further define the role of smoking in the etiology of cleft lip and palate.

Changes in the Transverse Dimension of the Maxillary Arch of 5-Year-Olds Born With UCLP Since the Introduction of Nationwide Guidance.

OBJECTIVE: To determine whether the transverse dimensions of the maxillary arch of 5-year-old children with unilateral cleft lip and palate (UCLP) have changed following centralization of cleft services in the United Kingdom. DESIGN: Retrospective cross-sectional study. SETTING: Digital analysis of UCLP maxillary dental casts. PARTICIPANTS: All available maxillary dental casts from 5-year-old participants of the Clinical Standards Advisory Group (CSAG, N = 114) and Cleft Care UK (CCUK, N = 175) studies. INTERVENTIONS: Quantitative measurements of the intercanine width (ICW), intermolar width (IMW), and the distance from the midline to the greater and lesser side canine (GC/LC) and greater side and lesser side second primary molar (GE/LE). Degree measurements of the greater and lesser arch form angles, arch length, anterior palatal depth (APD), and posterior palatal depth were also measured. MAIN OUTCOME: Differences between the transverse dimensions of the maxillary arch for the CSAG and CCUK cohorts. RESULTS: In 5 (ICW, IMW, LC, LE, and APD) of the 11 measurements, there was a statistically significant difference between the CSAG and CCUK cohorts. In all of these, the CCUK values were greater than CSAG. CONCLUSIONS: There have been small but positive improvements for the transverse maxillary dimensions since centralization of the UK cleft service.

Maternal Stressful Life Events During the Periconceptional Period and Orofacial Clefts: A Systematic Review and Meta-Analysis.

OBJECTIVE: To assess whether women who experience stressful life events during the periconceptional period are at higher risk of giving birth to a baby with an orofacial cleft (OFC). DESIGN: Systematic review and meta-analysis of studies reporting the proportion of babies born with OFC to mothers exposed and unexposed to population-level or personal-level stressful life events during the periconceptional period. Six electronic databases were searched from inception to August 2020. Risk of bias was assessed using the Newcastle-Ottawa scale. Odds ratios (ORs) for the odds of OFC in babies of exposed mothers relative to unexposed controls were extracted and/or calculated. Random effects meta-analysis was undertaken, stratified by cleft subtype. RESULTS: Of 12 eligible studies, 8 examined experience of personal events and 4 examined population-level events. Studies demonstrated low-moderate risk of bias and there was indication of publication bias. There was some evidence that personal stressful life events were associated with greater odds of cleft lip and/or palate (six studies, OR 1.63, 95% confidence interval (CI) 1.16, 2.30, P = 0.001) and cleft palate only (six studies, OR 1.45, 95% CI 1.02, 2.06, P = 0.04). Population-level events were associated with higher odds of OFC in studies that did not specify subtype (three studies, OR 1.64, 95% CI 1.19, 2.25, P = 0.002), but subtype stratified analyses were underpowered. Heterogeneity was high. CONCLUSIONS: Limited evidence indicated a weak positive association between maternal stressful life events during the periconceptional period and risk of OFC in the offspring, but further studies with greater consistency in research design are needed.

Investigating the shared genetics of non-syndromic cleft lip/palate and facial morphology.

There is increasing evidence that genetic risk variants for non-syndromic cleft lip/palate (nsCL/P) are also associated with normal-range variation in facial morphology. However, previous analyses are mostly limited to candidate SNPs and findings have not been consistently replicated. Here, we used polygenic risk scores (PRS) to test for genetic overlap between nsCL/P and seven biologically relevant facial phenotypes. Where evidence was found of genetic overlap, we used bidirectional Mendelian randomization (MR) to test the hypothesis that genetic liability to nsCL/P is causally related to implicated facial phenotypes. Across 5,804 individuals of European ancestry from two studies, we found strong evidence, using PRS, of genetic overlap between nsCL/P and philtrum width; a 1 S.D. increase in nsCL/P PRS was associated with a 0.10 mm decrease in philtrum width (95% C.I. 0.054, 0.146; P = 2x10-5). Follow-up MR analyses supported a causal relationship; genetic variants for nsCL/P homogeneously cause decreased philtrum width. In addition to the primary analysis, we also identified two novel risk loci for philtrum width at 5q22.2 and 7p15.2 in our Genome-wide Association Study (GWAS) of 6,136 individuals. Our results support a liability threshold model of inheritance for nsCL/P, related to abnormalities in development of the philtrum.

Educational Attainment of Children Born with Unilateral Cleft Lip and Palate in the United Kingdom.

OBJECTIVE: This study evaluated association between functional outcomes in children born with unilateral cleft lip and palate (UCLP) and educational attainment. DESIGN: Cleft Care UK (CCUK) was a United Kingdom (UK) wide cross-sectional study. SETTING: UK Cleft Teams (data collected from all UK sites providing centralized cleft services). PATIENTS, PARTICIPANTS: Five-year olds born with nonsyndromic UCLP (n = 268). MAIN OUTCOME MEASURE(S): National tests for educational attainment Key Stage 1 (KS1) undertaken by children at age 7 were linked to CCUK data to describe differences in educational attainment. Associations between functional outcomes and KS1 results were evaluated using regression analysis. We adjusted for birth month, gender, and an area-based measure of socioeconomic status. RESULTS: Data were available for 205 children with UCLP. These children scored lower than national average (NA) scores across all subject areas, with a 0.62 lower score observed in the Average Point Score (APS; P = .01). There was association between being in a lower category for a cleft related outcomes and poorer KS1 results, with a trend for poorer attainment with higher numbers of poor functional outcomes. Those with 3 or more poor outcomes had a -2.26 (-3.55 to -0.97) lower APS compared to those with 0 to 1 poor outcomes. CONCLUSIONS: Children born with UCLP have poorer educational attainment at age 7 across all subject areas though differences were modest. Children with poor functional outcomes at age 5 had worse educational outcomes age 7. Improvements in functional outcomes could enhance educational outcomes.

Range and timing of surgery, and surgical sequences used, in primary repair of complete unilateral cleft lip and palate: The Cleft Care UK study.

OBJECTS: To describe the range of surgery used to repair the lip and palate in the UK with specific interest in the sequence/timing used in complete unilateral cleft lip and palate (cUCLP). SETTING AND SAMPLE POPULATION: The Cleft Care UK study, a cross-sectional study of 268 5-year-olds, born from 2005 to 2007, with complete unilateral cleft lip and palate. MATERIALS & METHODS: Information on surgery was extracted from medical notes by surgeons during research clinics and transcribed onto a standardized questionnaire. RESULTS: Surgical data were available for 251 (94%) children from all cleft centres in the UK (n = 18). Over a two-year period, 32 surgeons used 10 different surgical sequences in primary repair of the cleft lip and palate. The most frequently used sequence was repair of cleft lip and anterior hard palate followed by repair of posterior hard palate and soft palate (70%). Four surgical sequences were used only once. Most surgeons had a preferred sequence, but 38% (11/29) used more than one sequence during the study period. The timing of repair of the lip, the hard palate and the soft palate varied with surgical sequence, and also between surgeons, even adjusting for the different sequences used. CONCLUSION: Despite centralization of cleft services in the UK, there remains considerable variation in both the sequence and timing of surgical repair of cleft lip and palate in infancy. Further work is required to understand whether these factors are associated with differences in outcome.

Closer to the Truth on National Fistula Prevalence After Unilateral Complete Cleft Lip and Palate Repair? The Cleft Care UK Study.

OBJECTIVES: To (1) determine the prevalence of nonperialveolar palatal fistula up to age 5 following repair of unilateral cleft lip and palate (UCLP) in the United Kingdom, (2) examine the association of palatoplasty techniques with fistula occurrence, and (3) describe the frequency of fistula repairs and their success. DESIGN: Cross-sectional study. SETTING: All 11 centralized regional cleft centers in the United Kingdom. PARTICIPANTS: Two hundred sixty-eight children born between 2005 and 2007 recruited by Cleft Care UK, a nationwide cross-sectional study of all 5-year-old children born with nonsyndromic UCLP. MAIN OUTCOME MEASURE: Nonperialveolar palatal fistula prevalence up to age 5. RESULTS: Fistulas were found in 72 children (31.3%, 95% confidence interval: 25.4%-37.7%) and had no significant association with palate repair sequences. Twenty-four fistulas were repaired by age 5, 12 of which had data showing 10 (83.3%) successful repairs. CONCLUSION: The prevalence of nonperialveolar fistulas following primary palatoplasty of UCLP in the United Kingdom was higher than previously reported. This information should be part of the preoperative discussion with families. Prospective collection of the presence of fistulas will be necessary before we can associate the occurrence of fistulas with a surgeon, institution, surgical technique, or protocol of care.

Is There a Correlation Between Nasolabial Appearance and Dentoalveolar Relationships in Patients With Repaired Unilateral Cleft Lip and Palate?

OBJECTIVE: To determine whether a relationship exists between the aesthetic scores given to photographic records of the nasolabial region of patients with repaired unilateral cleft lip and palate (UCLP) and the 5-Year Olds' Index scores of study models for the same participants. DESIGN: Retrospective study. SETTING: University of Bristol Dental Hospital, United Kingdom. PARTICIPANTS: Patients with nonsyndromic UCLP previously enrolled in the Cleft Care UK (CCUK) Study. METHODS: The CCUK participants, who had both study models and photographs (frontal and worm's eye view), were identified and their records retrieved. These were rated by 2 consultants and 2 senior registrars in orthodontics. The 5-Year Olds' Index was used to score the study models, and at a separate sitting, a 5-point Likert scale was used to score the cropped frontal and worm's eye view photographs of the same children. The results were analyzed using intraclass correlation coefficients and Cohen κ. MAIN OUTCOME MEASURES: Correlation between the aesthetic scores of the photographic views and the concordant 5-Year Olds' Index scores of the study models. RESULTS: The intraclass correlation coefficient scores showed very poor agreement between the photographic views and their concordant study models. The level of inter- and intra-rater reliability was strongest when scoring the study models. CONCLUSIONS: There was no agreement between the scores given to various photographic views and their corresponding study models. Scoring the study models using the 5-Year Olds' Index was the most reliable outcome measure for this age-group.

Outcome Measures in UCLP: The Modified 5-Year-Olds'-Index-Development and Reliability.

OBJECTIVE: Can we reliably discriminate severity within the existing categories of the 5-Year-Olds' Index? DESIGN: Retrospective method comparison and development study. SETTING: School of Oral and Dental Science, University of Bristol. METHODS: Dental study models of 5-year-olds with unilateral cleft lip and palate (UCLP) were collected from the archives of 2 national cleft surveys (n = 351). One hundred randomly selected models were ranked to construct the modified 5-Year-Olds' Index and also scored using a visual analogue scale (VAS). Reliability testing was performed on 51 study models. Visual analogue scale scores were used to aid statistical analysis and investigate the reliability of a VAS for outcome measurement. The modified 5-Year-Olds' Index was then applied to 198 study models of 5-year-olds with UCLP. RESULTS: The modified 5-Year-Olds' Index showed excellent intra and interexaminer agreement (intraclass correlation > 0.94) and good discrimination of severity. When applied to the Cleft Care UK participants (n = 198), the modified 5-Year-Olds' Index showed good discrimination of severity within the better categories (groups 1-3) of the 5-Year-Olds' Index. Visual analogue Scale scores resulted in unacceptable variation between measurements. CONCLUSIONS: The new modified 5-Year-Olds' Index is a reliable method of assessing outcomes at 5 years of age and showed improved discriminatory power between the "better" outcome categories than the original 5-Year-Olds' Index. A VAS was found to be unsuitable for assessing outcome at 5 years of age for children with UCLP.

Particulate production during debonding of fixed appliances: Laboratory investigation and randomized clinical trial to assess the effect of using flash-free ceramic brackets.

INTRODUCTION: The aim of this laboratory and randomized clinical trial was to investigate particulate production at debonding and enamel clean-up following the use of flash-free ceramic brackets and to compare them with non-flash-free metal and ceramic brackets. METHODS: In the laboratory study, brackets were bonded to bovine teeth. After 24 hours of immersion in water, the brackets were debonded, the adhesive remnant scores noted, and the enamel cleaned with the use of rotary instruments. Four bracket-adhesive combinations and 2 different enamel pretreatment regimens were tested, including metal and ceramic brackets (conventional, adhesive precoat [APC], and APC flash-free) and conventional acid etch and self-etching primer. Quantitative (mg/m3) and qualitative analysis of particulate production was made in each case. In the clinical trial, 18 patients treated with the use of fixed appliances were recruited into this 3-arm parallel-design randomized controlled trial. They were randomly allocated to 1 of 3 groups: experimental flash-free ceramic bracket or non-flash-free ceramic or metal bracket group. Eligibility criteria included patients undergoing nonextraction maxillary and mandibular fixed appliance therapy. At completion of treatment, the brackets were debonded, and the primary outcome measure was particulate concentration (mg/m3). Randomization was by means of sealed envelopes. Data were analyzed with the use of quantile plots and linear mixed models. The effect of etch, bracket, and stage of debonding of clean-up on particle composition was analyzed with the use of mixed-effects regression. RESULTS: In the laboratory study, the APC brackets produced the highest particulate concentration. Although statistically significantly higher than the metal and conventional ceramic brackets, it was not significantly higher than the ceramic flash-free brackets. In the clinical study, there was no statistically significant effect of bracket type on particulate concentration (P = 0.29). This was despite 3 patients with APC flash-free and 1 patient with conventional Clarity (with 1 bracket) having 1 or more ceramic bracket fracture at debonding requiring removal. No adverse events reported. CONCLUSIONS: Particulates in the inhalable, thoracic, and respirable fractions were produced at enamel clean-up with all bracket types. Although APC and APC flash-free brackets produced the highest concentrations in the laboratory study, there was no difference between any of the brackets in the clinical trial. REGISTRATION: The trial was not registered. FUNDING: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Making a difference for children born with a cleft in the UK.

This short review is an opportunity to focus on significant positive changes for those children born with some form of oro-facial clefting and who are treated in a centralised service within the National Health Service (NHS). There has also been an opportunity to provide a focus for research as part of this service model. Orthodontists have played a key role in all aspects of this and will continue to be central to further improvements in caring for cleft children.

National British Orthodontic Society (BOS) Orthognathic Audit 2017-2018.

OBJECTIVE: To carry out a UK national clinical audit of orthognathic acceptance criteria and information provided to orthognathic patients before treatment. DESIGN: National clinical audit. SETTING: Data collected using Bristol Online Surveys. PARTICIPANTS: Sixty-nine UK hospital orthodontic departments submitted data. METHODS: Data were collected at two time points using Bristol Online Surveys over a period of 12 months. These were before treatment at the first multidisciplinary clinic (MDT) and immediately after surgery. The data collected included: Index of Orthognathic Functional Treatment Need (IOFTN); Index of Orthodontic Treatment Need (IOTN); age; previous orthodontic treatment; attendance at an MDT; treatment times; and information provision. RESULTS: Eighty-five units agreed to take part in the audit with 69 submitting data, giving a response rate of 81%. The data from 3404 patients were uploaded, 2263 before treatment and 1141 immediately after surgery. Of patients, 91.07% had an IOFTN score of 4 or 5 and 88.73% had an IOTN score of 4 or 5. The mean age at the first MDT was 22 years in the first cohort and 21 years and 4 months in the second immediate post-surgery cohort. Of patients, 37.93% had undergone some form of previous orthodontic treatment, but only 0.28% had undergone previous orthognathic treatment; 96.93% had an MDT confirm that orthodontic treatment by itself was insufficient to adequately correct their functional symptoms. The average treatment time from bond up to surgery was 2 years and 6 months. With respect to information provision, patients received information from a number of sources, principally the British Orthodontic Society (BOS) patient information leaflets and the BOS website Your Jaw Surgery. CONCLUSIONS: In the UK, the majority of orthognathic cases fulfil the criteria for acceptance for NHS-funded orthognathic treatment, as outlined by the Chief Dental Officer's interim guidance on orthognathic treatment. This suggests any prior approval process would not be a good use of NHS resources in the commissioning of orthognathic treatment.

Setting up a cohort study in speech and language therapy: lessons from The UK Cleft Collective Speech and Language (CC-SL) study.

BACKGROUND: Efforts to increase the evidence base in speech and language therapy are often limited by methodological factors that have restricted the strength of the evidence to the lower levels of the evidence hierarchy. Where higher graded studies, such as randomized controlled trials, have been carried out, it has sometimes been difficult to obtain sufficient power to detect a potential effect of intervention owing to small sample sizes or heterogeneity in the participants. With certain clinical groups such as cleft lip and palate, systematic reviews of intervention studies have shown that there is no robust evidence to support the efficacy of any one intervention protocol over another. AIMS: To describe the setting up of an observational clinical cohort study and to present this as an alternative design for answering research questions relating to prevalence, risk factors and outcomes from intervention. METHODS: The Cleft Collective Speech and Language (CC-SL) study is a national cohort study of children born with cleft palate. Working in partnership with regional clinical cleft centres, a sample size of over 600 children and 600 parents is being recruited and followed up from birth to age 5 years. Variables being collected include demographic, psychological, surgical, hearing, and speech and language data. MAIN CONTRIBUTION: The process of setting up the study has led to the creation of a unique, large-scale data set which is available for researchers to access now and in future. As well as exploring predictive factors, the data can be used to explore the impact of interventions in relation to individual differences. Findings from these investigations can be used to provide information on sample criteria and definitions of intervention and dosage which can be used in future trials. CONCLUSIONS: The observational cohort study is a useful alternative design to explore questions around prevalence, risk factors and intervention for clinical groups where robust research data are not yet available. Findings from such a study can be used to guide service-delivery decisions and to determine power for future clinical trials.

Recruiting to cohort studies in specialist healthcare services: Lessons learned from clinical research nurses in UK cleft services.

AIMS AND OBJECTIVES: To explore the experiences of clinical research nurses recruiting patients in a large specialist care-based cohort study. BACKGROUND: Longitudinal studies are vital to better understand the aetiology and moderators of health conditions. This need is especially salient for congenital conditions, such as cleft lip and/or palate, where establishing large, comprehensive data sets from birth is vital to improve understanding and to inform interventions. Various barriers exist in recruiting patients to large cohort studies. The role of clinical research nurses embedded within health settings has grown over past decades to facilitate data collection, yet challenges remain. DESIGN: Qualitative descriptive study. METHODS: Individual semi-structured interviews with 12 clinical research nurses based in 10 National Health Service cleft services across the UK, recruiting to the Cleft Collective Birth Cohort Study. RESULTS: Of seven emergent themes, three highlighted challenges to recruiting patients, another three described facilitative factors, and one theme overlapped challenges and facilitators. Challenges included the life circumstances of potential participants; language barriers; and limited clinical research nurse time for study. Facilitative factors included integrating research into clinical practice; patient information shared with clinical research nurses; and support from the university-based research study team. The theme "Method of data collection" related to both challenges and facilitators. CONCLUSIONS: The qualitative data from clinical research nurses recruiting to a large birth cohort study provide helpful practical detail for specialist healthcare teams, specialist nurses, clinical research nurses and researchers looking to optimise recruitment and data collection in longitudinal studies. RELEVANCE TO CLINICAL PRACTICE: The findings suggest the importance of specialist clinical services and research study teams cooperating to embed research into everyday clinical practice, without compromising care. This should facilitate patients' willingness to participate in important research like the Cleft Collective study and provide them with a positive experience of research.

Centralization of Cleft Lip and Palate Services in the United Kingdom: The Views of Adult "Returners".

BACKGROUND: Since the implementation of centralized services in the United Kingdom for those affected by cleft lip and/or palate (CL/P), several studies have investigated the impact of service rationalization on the delivery of care. While large-scale quantitative studies have demonstrated improvements in a range of patient outcomes, and smaller studies have reported on the benefits and challenges of centralization from the views of health professionals, little research has attempted to capture the patient perspective. Furthermore, few studies have investigated the views of adult "returners" who have undergone treatment both pre- and postcentralization. METHODS: Qualitative data relevant to the subject of this article were extracted from 2 previous larger studies carried out between January 2013 and March 2014. A total of 16 adults born with CL/P contributed data to the current study. These data were subjected to inductive thematic analysis. RESULTS: The findings suggest that centralization of CL/P services has considerably enhanced the patient experience. Specifically, the overall standard and coordination of care has improved, service delivery has become more patient centered, and access to professional psychological support and peer support has greatly improved patients' capacity to cope with the associated emotional challenges. CONCLUSIONS: The data collected provide additional insight into the impact of centralization from the perspective of a largely unexplored patient population. In combination with other literature, these findings are also relevant to future efforts to centralize other specialist services around the world.

Closing the Loop on Centralization of Cleft Care in the United Kingdom.

OBJECTIVE: We highlight a major study that investigated the impact of reconfigured cleft care in the United Kingdom some 15 years after centralization. We argue that centralization as an intervention has a major impact on outcomes. SETTING: Audit clinics held in Cleft Centers in the United Kingdom. PATIENTS, PARTICIPANTS: Five-year-olds born between April 1, 2005, and March 31, 2007, with nonsyndromic unilateral cleft lip and palate. INTERVENTIONS: Centralization of cleft care. MAIN OUTCOME MEASURE(S): We collected routine clinical measures (speech recordings, hearing, photographs, models, oral health, psychosocial factors) in a very similar way to a previous survey. RESULTS: We identified 359 eligible children and recruited 268 (74.7%) to the study. Overall, their outcomes were better post-centralization. There have been marked improvements in dentoalveolar arch relationships and in speech whereas the prevalence of dental caries and hearing loss are unchanged. CONCLUSIONS: Centralized cleft care has changed UK outcomes considerably and there is no argument for returning to a dispersed model of treatment.

Chewing gum vs. ibuprofen in the management of orthodontic pain, a multi-centre randomised controlled trial - the effect of anxiety.

OBJECTIVES: Pain is a common side effect of orthodontic treatment. An objective of this study, part of a large previously reported RCT on pain and analgesic use, was to determine the effect of anxiety on perceived pain and use of analgesia. METHODS: 1000 patients aged 11-17 years, undergoing upper and lower fixed appliance treatment in nine hospital departments were recruited into this two-arm parallel design randomised controlled trial. One arm was given sugar-free chewing gum and the other arm ibuprofen for pain relief. Neither the clinicians nor patients were blinded to assignment. In addition to recording pain experience and analgesic use for 3 days following appliance placement and first archwire change, each patient recorded their level of anxiety immediately following the fitting of the appliance and the first archwire change. RESULTS: 419 chewing gum group (84%) and 407 ibuprofen group (83%) questionnaires were returned following appliance placement, and 343 chewing gum group (70%) and 341 ibuprofen group (71%) questionnaires were returned following the first archwire change. The mean anxiety scores following fitting of the appliance and first archwire change were 2.7 (SD 2.1) and 1.6 (SD 1.8), respectively. There were weak but significant positive associations between anxiety scores and pain scores. Multi-level modelling produced a coefficient for anxiety of 0.23 (95% CI 0.17-0.28) for appliance placement, suggesting a small rise (0.23) on the 11-point pain scale for a one-point increase on the corresponding anxiety scale. Following archwire change, the corresponding coefficient was 0.32 (0.24-0.39). For ibuprofen use, again simple analyses suggested a relationship with anxiety. Multi-level logistic modelling produced an odds ratio for ibuprofen use of 1.11 (95% CI 1.07-1.15) at appliance placement and 1.21 (1.10-1.33) at the first archwire change. There was a 10-20% increase in the odds of using ibuprofen for each one-point increase on the anxiety scale. No such relationship was found between anxiety and chewing gum use. There were no adverse effects or harms reported during the trial. Approvals were granted by the Research Ethics Committee (08/H0106/139), R&D and MHRA (Eudract 2008-005522-36) and the trial was registered on the ISRCTN (79884739) and NIHR (6631) portfolios. Support was provided by the British Orthodontic Society Foundation. CONCLUSIONS: There was a weak positive correlation between anxiety reported and pain experienced following both the initial fitting of the fixed appliances and at the subsequent archwire change. Patients that were more anxious tended to take more ibuprofen for their pain relief.