The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia.

BACKGROUND: Child anxiety before general anaesthesia and surgery is common. Midazolam is a commonly used premedication to address this. Melatonin is an alternative anxiolytic, however trials evaluating its efficacy in children have delivered conflicting results. METHODS: This multicentre, double-blind randomised trial was performed in 20 UK NHS Trusts. A sample size of 624 was required to declare noninferiority of melatonin. Anxious children, awaiting day case elective surgery under general anaesthesia, were randomly assigned 1:1 to midazolam or melatonin premedication (0.5 mg kg-1, maximum 20 mg) 30 min before transfer to the operating room. The primary outcome was the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Secondary outcomes included safety. Results are presented as n (%) and adjusted mean differences with 95% confidence intervals. RESULTS: The trial was stopped prematurely (n=110; 55 per group) because of recruitment futility. Participants had a median age of 7 (6-10) yr, and 57 (52%) were female. Intention-to-treat and per-protocol modified Yale Preoperative Anxiety Scale-Short Form analyses showed adjusted mean differences of 13.1 (3.7-22.4) and 12.9 (3.1-22.6), respectively, in favour of midazolam. The upper 95% confidence interval limits exceeded the predefined margin of 4.3 in both cases, whereas the lower 95% confidence interval excluded zero, indicating that melatonin was inferior to midazolam, with a difference considered to be clinically relevant. No serious adverse events were seen in either arm. CONCLUSION: Melatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias. CLINICAL TRIAL REGISTRATION: ISRCTN registry: ISRCTN18296119.

Are oral health conditions associated with schoolchildren's performance and school attendance in the Kingdom of Bahrain? A life-course perspective.

BACKGROUND: The link between oral diseases and school performance and school attendance remains unclear among Middle Eastern children. AIM: To investigate the relationship of oral conditions with schoolchildren's school performance and attendance using the life-course approach. DESIGN: A cross-sectional study was conducted with 466 schoolchildren aged 7-8 years from Kingdom of Bahrain (KoB) and their parents. Questionnaire data on children's current and at-birth environmental characteristics were completed by their parents. Children's oral health measures, including ICDAS (International Caries Detection and Assessment System), PUFA (pulp, ulcer, fistula, abscess), and DDE (developmental defects of enamel) indices, were the exposure variables. School performance and school attendance data obtained from the school register were the outcome variables. The data were analysed using multivariate ordinal logistic regression. RESULTS: The odds of excellent school performance were significantly lower for children with untreated dentinal caries (OR = 0.98; 95% CI: 0.96-0.99). Children with caries-treated teeth showed greater odds of excellent school performance (OR = 1.41; 95% CI: 1.15-1.74). Disease Control and PreventionNone of the dental conditions were significantly associated with children's school attendance. A permissive parental style was associated with poor school attendance (OR = 2.63; 95% CI: 1.08-6.42). CONCLUSION: Dental caries was associated with poor school performance but not with school attendance. Treated caries was associated with good school performance.

CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol.

BACKGROUND: Comprehensive caries care has shown effectiveness in controlling caries progression and improving health outcomes by controlling caries risk, preventing initial-caries lesions progression, and patient satisfaction. To date, the caries-progression control effectiveness of the patient-centred risk-based CariesCare International (CCI) system, derived from ICCMS™ for the practice (2019), remains unproven. With the onset of the COVID-19 pandemic a previously planned multi-centre RCT shifted to this "Caries OUT" study, aiming to assess in a single-intervention group in children, the caries-control effectiveness of CCI adapted for the pandemic with non-aerosols generating procedures (non-AGP) and reducing in-office time. METHODS: In this 1-year multi-centre single-group interventional trial the adapted-CCI effectiveness will be assessed in one single group in terms of tooth-surface level caries progression control, and secondarily, individual-level caries progression control, children's oral-health behaviour change, parents' and dentists' process acceptability, and costs exploration. A sample size of 258 3-5 and 6-8 years old patients was calculated after removing half from the previous RCT, allowing for a 25% dropout, including generally health children (27 per centre). The single-group intervention will be the adapted-CCI 4D-cycle caries care, with non-AGP and reduced in-office appointments' time. A trained examiner per centre will conduct examinations at baseline, at 5-5.5 months (3 months after basic management), 8.5 and 12 months, assessing the child's CCI caries risk and oral-health behaviour, visually staging and assessing caries-lesions severity and activity without air-drying (ICDAS-merged Epi); fillings/sealants; missing/dental-sepsis teeth, and tooth symptoms, synthetizing together with parent and external-trained dental practitioner (DP) the patient- and tooth-surface level diagnoses and personalised care plan. DP will deliver the adapted-CCI caries care. Parents' and dentists' process acceptability will be assessed via Treatment-Evaluation-Inventory questionnaires, and costs in terms of number of appointments and activities. Twenty-one centres in 13 countries will participate. DISCUSSION: The results of Caries OUT adapted for the pandemic will provide clinical data that could help support shifting the caries care in children towards individualised oral-health behaviour improvement and tooth-preserving care, improving health outcomes, and explore if the caries progression can be controlled during the pandemic by conducting non-AGP and reducing in-office time. TRIAL REGISTRATION: Retrospectively-registered-ClinicalTrials.gov-NCT04666597-07/12/2020: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000AGM4&selectaction=Edit&uid=U00019IE&ts=2&cx=uwje3h . Protocol-version 2: 27/01/2021.

Reproducibility of subtraction radiography in monitoring changes in approximal carious lesions in children: An in vivo study.

BACKGROUND: Laboratory studies have shown that digital subtraction radiography (DSR) can be a more effective tool, than conventional radiography, in monitoring changes in carious lesions. The clinical performance of the technique, however, has not been sufficiently researched. AIM: To compare the reproducibility of DSR to that of bitewing radiographs, in monitoring changes in approximal caries in the mixed dentition. A secondary aim was to determine whether assessment outcomes differed as a function of the method used. DESIGN: Six assessors evaluated 310 lesions first on bitewings, then with DSR. The overall reproducibility was evaluated via intra-class correlation coefficient (ICC). Intra- and inter-rater reproducibility were assessed using weighted Kappa. Paired t test was used to assess differences in the reproducibility across methods. RESULTS: The overall reproducibility for DSR was (ICC = 0.47, 95% CI = 0.31-0.56). Intra- and inter-rater reproducibility were 0.65 and 0.44, respectively. The overall reproducibility for bitewings was ICC = 0.45, 95% CI = 0.42-0.57. Intra- and Inter-rater reproducibility were 0.71 and 0.46, respectively. Differences in the reproducibility across methods were not statistically significant. Significantly more lesions were scored as progressed using DSR. CONCLUSIONS: The reproducibility of DSR in monitoring changes in approximal caries is comparable to that of bitewings. Additionally, DSR detected higher proportion of progression than bitewing assessments.

Physical activity calorie expenditure (PACE) labels in worksite cafeterias: effects on physical activity.

BACKGROUND: Regular physical activity is an important component of healthy living and wellbeing. Current guidelines recommend that adults participate in at least 150 min of moderate or vigorous-intensity physical activity weekly. In spite of the benefits, just over half of U.S. adults meet these recommendations. Calorie-only food labels at points of food purchase have had limited success in motivating people to change eating behaviors and increase physical activity. One new point of purchase approach to promote healthy behaviors is the addition of food labels that display the physical activity requirement needed to burn the calories in a food item (e.g. walk 15 min). METHODS: The Physical Activity Calorie Expenditure (PACE) Study compared activity-based calorie-expenditure food labels with calorie-only labels at three Blue Cross and Blue Shield of North Carolina worksite cafeterias. After 1 year of baseline data collection, one cafeteria had food items labeled with PACE labels, two others had calorie-only food labels. Cohort participants were asked to wear an accelerometer and complete a self-report activity questionnaire on two occasions during the baseline year and twice during the intervention year. RESULTS: A total of 366 study participants were included in the analysis. In the PACE-label group, self-reported physical activity increased by 13-26% compared to the calorie-only label group. Moderate-to-vigorous physical activity (MVPA) increased by 24 min per week in the PACE-label group compared to the calorie-label group (p = 0.06). Changes in accelerometer measured steps, sedentary time, and MVPA had modest increases. Change ranged from 1 to 12% with effect size values from 0.08 to 0.15. Baseline physical activity level significantly moderated the intervention effects for all physical activity outcomes. Participants in both label groups starting in the lowest tertile of activity saw the largest increase in their physical activity. CONCLUSION: Results suggest small positive effects for the PACE labels on self-reported and objective physical activity measures. Minutes of weekly MVPA, strength training, and exercise activities showed modest increases. These results suggest that calorie-expenditure food labels may result in some limited increases in physical activity.

Fissure seal or fluoride varnish?

Data sourcesCochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, the US National Institutes of Health Trials Register and the World Health Organization (WHO) Clinical Trials Registry PlatformStudy selectionRandomised controlled trials (RCTs) with at least 12 months follow-up, in which fissure sealants, or fissure sealants together with fluoride varnishes, were compared with fluoride varnishes alone for preventing caries in occlusal surfaces of permanent teeth of children and adolescents.Data extraction and synthesisTwo reviewers independently screened search results, extracted data and assessed risk of bias of included studies. Studies were grouped and analysed on the basis of sealant material type (resin-based sealant and glass ionomer-based sealant, glass ionomer and resin-modified glass ionomer) and different follow-up periods. Odds ratio were calculated for caries or no caries on occlusal surfaces of permanent molar teeth. Mean differences were calculated for continuous outcomes and data. Evidence quality was assessed using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.ResultsEight RCTs involving a total of 1747 children aged five to ten years of age were included. Three trials compared resin-based fissure sealant versus fluoride varnish. Results from two studies (358 children) after two years were combined. Sealants prevented more caries, pooled odds ratio (OR) = 0.69 (95%CI; 0.50 to 0.94). One trial with follow-up at four and nine years found that the caries-preventive benefit for sealants was maintained, with 26% of sealed teeth and 55.8% of varnished teeth having developed caries at nine years. Evidence for glass-ionomer sealants was of low quality. One split-mouth trial analysing 92 children at two-year follow-up found a significant difference in favour of resin-based fissure sealant together with fluoride varnish compared with fluoride varnish only (OR 0.30, 95% CI 0.17 to 0.55). The evidence was assessed as low quality. Three studies assessed but did not report any adverse effects.ConclusionsCurrently, scarce and clinically diverse data are available on the comparison of sealants and fluoride varnish applications; therefore it is not possible to draw clear conclusions about possible differences in effectiveness for preventing or controlling dental caries on occlusal surfaces of permanent molars. The conclusions of this updated review remain the same as those of the last update (in 2010). We found some low quality evidence suggesting the superiority of resin-based fissure sealants over fluoride varnish applications for preventing occlusal caries in permanent molars, and other low-quality evidence for benefits of resin-based sealant and fluoride varnish over fluoride varnish alone. Regarding glass ionomer sealant versus fluoride varnish comparisons, we assessed the quality of the evidence as very low and could draw no conclusions.

The relationship of children's dental clinical status with school performance and school attendance in the Kingdom of Bahrain: A life-course approach.

OBJECTIVES: To examine the association between dental clinical status and school performance and school attendance in the Kingdom of Bahrain (KoB) using a life-course framework. METHODS: This time-ordered cross-sectional study included 466 school children in Grade 2 (aged 7-8 years) and their parents in the KoB. Data were collected through parents' self-administered questionnaires, children's face-to-face interviews and dental clinical examinations. Data on children's school performance and school attendance were gathered from parents and school records. Structural equation modelling (SEM) examined the direct and indirect pathways between variables. RESULTS: Children born in families with high socio-economic status (SES) were less likely to have dental caries and more likely to have better school performance at 7-8 years of age. Dentine caries was directly linked with poor school performance. Treated teeth directly predicted high school performance. The presence of dentine caries mediated the relationship of SES with school performance. CONCLUSIONS: Birth and current socio-economic factors were significant predictors of dental clinical conditions and school performance. Dental caries and fewer treated teeth directly predicted poor school performance.

Personalised versus standard text message prompts for increasing trial participant response to telephone follow-up: an embedded randomised controlled retention trial.

BACKGROUND: Improving retention within randomised controlled trials is important. The effectiveness of different strategies can be assessed using a Study Within A Trial (SWAT). Previous research has shown personalised text message reminders improve clinic attendance rates; however, the results are mixed on improving postal questionnaire return. This SWAT aims to assess whether personalised text message reminders improve completion rates for scheduled telephone follow-ups. METHODS: This SWAT is a two-arm, multi-centre randomised controlled trial with equal allocation. The host trial was the Melatonin for Anxiety prior to General anaesthesia In Children trial (ISRCTN 18296119), where the child's caregiver was to answer a scheduled telephone follow-up 14 days post-surgery; participants for the SWAT were therefore the caregiver. Text messages were sent 24-48 h before the scheduled call and the personalised version contained the first name of the caregiver which was omitted in the non-personalised version. The primary outcome was questionnaire completion rate, defined as the proportion of caregivers successfully contacted, and completed any of the questionnaires, over the telephone within the follow-up window (day 14 + 7 days). RESULTS: The SWAT included 100 of the 110 (91%) participants randomised into the host trial. Randomisation within the SWAT was equal between non-personalised (n = 50) and personalised (n = 50) interventions. The overall questionnaire response rate was 73% with a difference between the two interventions of 68% in the non-personalised text message arm and 78% in the personalised text message arm. The adjusted absolute risk difference was 7.1% (95% confidence interval = -10.2%, 24.4%). There was no difference in either the time to response or the number of contact attempts between the two interventions. CONCLUSIONS: There is some evidence that personalised text messages could be effective at increasing response rates when data is collected via telephone and in a population of caregivers for paediatric trial participants. However, similar SWATs have shown mixed results. Given the low-cost and low risks associated with personalising text message reminders, this SWAT could be implemented easily in other RCTs scheduling telephone follow-up appointments. TRIAL REGISTRATION: ISRCTN 18296119 , SWAT 35 (MRC Northern Ireland Network for Trials Methodology Network).

What is the most accurate method for detecting caries lesions? A systematic review.

OBJECTIVE: To perform a systematic review and meta-analysis of the performance of different methods for detecting carious lesions in permanent and primary teeth, considering all types of tooth surface. METHODS: Two reviewers searched PubMed, Embase, Scopus and other sources up to November 2020 to identify published and nonpublished studies in English. We focused on three caries detection methods: visual inspection (VI), radiographic (RX) and fluorescence-based (LF). We included studies investigating at least one of these methods which (a) assessed the accuracy of the method in detecting caries lesions; (b) considered occlusal, proximal or free smooth surfaces in primary or permanent teeth; (c) used a reference standard other than one of the three methods; and (d) reported data on sample size and accuracy. Multilevel analyses, meta-regressions and comparisons of bivariate summary receiver operating characteristics curves were undertaken. RESULTS: Two hundred and forty manuscripts from 14 129 articles initially identified met the inclusion criteria. VI was better than RX on occlusal surfaces at all caries lesion thresholds and proximal surfaces of permanent teeth only at all lesion thresholds in laboratory setting. LF was slightly better than VI for advanced lesions on occlusal surfaces of permanent teeth in the clinical setting and for all lesions on proximal surfaces of permanent teeth in the laboratory setting. Still, LF was worse than VI for advanced occlusal lesions in permanent teeth in the laboratory setting. Although LF showed slightly better performance than VI with advanced lesions, the latter had significantly higher specificity than other methods in all settings. CONCLUSION: Visual caries detection alone is adequate for most patients in daily clinical practice regardless of tooth type or surface.

The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation.

BACKGROUND: Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants-CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon. METHODS: A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/ NCT03520309 ), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children's restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children's oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon. DISCUSSION: The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions. TRIAL REGISTRATION: NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

The FiCTION trial: Child oral health-related quality of life and dental anxiety across three treatment strategies for managing caries in young children.

OBJECTIVES: The FiCTION trial compared co-primary outcomes (dental pain and/or infection) and secondary outcomes (child oral health-related quality of life [COHRQOL], child dental anxiety, cost-effectiveness, caries development/progression and acceptability) across three treatment strategies (Conventional with Prevention [C + P]; Biological with Prevention [B + P]; Prevention Alone [PA]) for managing caries in children in primary care. COHRQOL and child dental anxiety experiences are reported upon here. METHODS: A multi-centre, 3-arm, parallel-group, unblinded patient-randomized controlled trial of 3- to 7-year-olds treated under NHS contracts was conducted in 72 general dental practices in England, Wales and Scotland. Child participants (with at least one primary molar with dentinal caries) were randomized (1:1:1) to one of three treatment arms with the intention of being managed according to allocated arm for 3 years (minimum 23 months). Randomization was via a centrally administered system using random permuted blocks of variable length. At baseline and final visit, accompanying parents/caregivers completed a parental questionnaire including COHRQOL (16 item P-CPQ-16), and at every visit, child- and parental-questionnaire-based data were collected for child-based dental trait and state anxiety. Statistical analyses were conducted on complete cases from the modified intention-to-treat (mITT) analysis set. RESULTS: A total of 1144 children were randomized (C + P: 386; B + P: 381; PA: 377). The mITT analysis set included the 1058 children who attended at least one study visit (C + P: 352; B + P: 352; PA: 354). Median follow-up was 33.8 months (IQR: 23.8, 36.7). The P-CPQ-16 overall score could be calculated after simple imputation at both baseline and final visit for 560 children (C + P: 189; B + P: 189; PA: 182). There was no evidence of a difference in the estimated adjusted mean P-CPQ-16 at the final visit which was, on average, 0.3 points higher (97.5% CI: -1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: -1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow-up visits. CONCLUSIONS: The differences noted in COHRQOL and child-based dental trait and dental state anxiety measures across three treatment strategies for managing dental caries in primary teeth were small, and not considered to be clinically meaningful. The findings highlight the importance of including all three strategies in a clinician's armamentarium, to manage childhood caries throughout the young child's life and achieve positive experiences of dental care.

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT.

BACKGROUND: Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. OBJECTIVES: The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. DESIGN: This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. SETTING: This trial was set in primary dental care in Scotland, England and Wales. PARTICIPANTS: Participants were NHS patients aged 3-7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. INTERVENTIONS: Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). MAIN OUTCOME MEASURES: The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. RESULTS: A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8-36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was -0.02 (97.5% confidence interval -0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval -0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. CONCLUSIONS: There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period. FUTURE WORK: Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77044005. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 1. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Tooth decay is common; it can lead to pain, days off school for children and days off work for parents and is a financial burden to the NHS. There is uncertainty about the best way of managing decay in young children. This trial aimed to find out whether or not there was a difference in the amount of pain and/or infection suffered by children having their decay treated with one of the following: fillings, having decay sealed in or using preventative treatment alone. Which method represented the best value was also explored. WHAT DID WE DO?: For young children with decay, the Filling Children's Teeth: Indicated Or Not? (FiCTION) trial compared the difference between fillings, sealing in the decay and using preventative treatment alone over 3 years in NHS dental practices in Scotland, England and Wales. We recruited 1144 children aged 3­7 years with one or more holes in their baby back teeth (molars), but without pain/infection, and placed them at random into one of three groups: (1) tooth numbing, removing decay and filling(s) with preventative treatment; (2) sealing in decay with fillings or caps and preventative treatment but no numbing; or (3) preventative treatment alone. WHAT DID WE FIND?: Recruitment was challenging but was achieved. There was no evidence of a difference in children's experience of pain or infection, quality of life or dental anxiety between groups. All three ways of treating decay were acceptable to children, parents and dental professionals. Sealing in with preventative treatment was most likely to be considered the best way of managing children's decay if we are willing to pay a minimum of £130 to avoid an episode of pain or infection. WHAT DOES THIS MEAN?: As there was no evidence of a difference between the three treatment groups in pain/infection experienced, treatment choice should continue to be based on shared decision-making between the child, parent and clinician to agree the best option for the individual child.

CariesCare practice guide: consensus on evidence into practice.

This CariesCare practice guide is derived from the International Caries Classification and Management System (ICCMS) and provides a structured update for dentists to help them deliver optimal caries care and outcomes for their patients. This '4D cycle' is a practice-building format, which both prevents and controls caries and can engage patients as long-term health partners with their practice. CariesCare International (CCI™) promotes a patient-centred, risk-based approach to caries management designed for dental practice. This comprises a health outcomes-focused system that aims to maintain oral health and preserve tooth structure in the long-term. It guides the dental team through a four-step process (4D system), leading to personalised interventions: 1st D: Determine Caries Risk; 2nd D: Detect lesions, stage their severity and assess their activity status; 3rd D: Decide on the most appropriate care plan for the specific patient at that time; and then, finally, 4th D: Do the preventive and tooth-preserving care which is needed (including risk-appropriate preventive care; control of initial non-cavitated lesions; and conservative restorative treatment of deep dentinal and cavitated caries lesions). CariesCare International has designed this practice-friendly consensus guide to summarise best practice as informed by the best available evidence. Following the guide should also increase patient satisfaction, involvement, wellbeing and value, by being less invasive and more health-focused. For the dentist it should also provide benefits at the professional and practice levels including improved medico-legal protection.

Quality of trials in a systematic review of powered toothbrushes: suggestions for future clinical trials.

BACKGROUND: This study aimed to assess the quality of reports of randomized controlled trials (RCTs) comparing manual and powered toothbrushes and provide advice on how future trials might be improved. METHODS: Studies were identified in the Cochrane systematic review of RCTs comparing powered versus manual toothbrushes. Reports were assessed against predefined criteria on the design of the studies to determine the effectiveness of the brushes in everyday home use and on their methodological quality. RESULTS: Only 42 of 297 identified studies satisfied the inclusion criteria and were eligible for inclusion in the review. Many studies were excluded for more than one reason. Fifteen studies employed split-mouth designs that may have changed toothbrushing behavior. Of 42 included RCTs, the generation of randomization sequence was adequate in 15 trials and concealment of allocation was adequate in 16 trials. Intention-to-treat analysis was reported in only five studies. Plaque data were reported using 10 different indices and gingivitis with nine indices. Only 12 trials lasted 3 months or longer, and there were no data on the benefits of powered toothbrushes for periodontal attachment. CONCLUSIONS: Some designs created an artificial research environment that may have undermined the findings. Authors of toothbrush trials should consider the Consolidated Standards of Reporting Trials statement. Greater standardization of the indices used is required. Trials of longer duration would enhance the evaluation of powered toothbrushes. Data on thresholds for clinically significant differences in plaque and gingivitis levels would help to determine whether oral hygiene aids provide important health benefits.

Evaluating community-based medical education programmes in Africa: A workshop report.

BACKGROUND: The Medical Education Partnership Initiative (MEPI) supports medical schools in Africa to increase the capacity and quality of medical education, improve retention of graduates, and promote regionally relevant research. Many MEPI programmes include elements of community-based education (CBE) such as: community placements; clinical rotations in underserved locations, community medicine, or primary health; situational analyses; or student-led research. METHODS: CapacityPlus and the MEPI Coordinating Center conducted a workshop to share good practices for CBE evaluation, identify approaches that can be used for CBE evaluation in the African context, and strengthen a network of CBE collaborators. Expected outcomes of the workshop included draft evaluation plans for each school and plans for continued collaboration among participants. The workshop focused on approaches and resources for evaluation, guiding exploration of programme evaluation including data collection, sampling, analysis, and reporting. Participants developed logic models capturing inputs, activities, outputs, and expected outcomes of their programmes, and used these models to inform development of evaluation plans. This report describes key insights from the workshop, and highlights plans for CBE evaluation among the MEPI institutions. RESULTS: Each school left the workshop with a draft evaluation plan. Participants agreed to maintain communication and identified concrete areas for collaboration moving forward. Since the workshop's conclusion, nine schools have agreed on next steps for the evaluation process and will begin implementation of their plans. CONCLUSION: This workshop clearly demonstrated the widespread interest in improving CBE evaluation efforts and a need to develop, implement, and disseminate rigorous approaches and tools relevant to the African context.

Predicting the experience of dentinal caries or restorative dental treatment in adolescents using D1 and D3 visual caries assessments.

Standardised epidemiological caries assessments used in oral health surveys have been shown to be poor at predicting whether a tooth surface will be treated restoratively when a patient visits a dentist. However, it has been argued that oral health surveys may be more relevant in determining needs at the level of an individual or groups of individuals. The objective of this study was to determine the discriminatory power of visual caries assessments at two thresholds (D1 & D3) in adolescents of average age 12.1 years to predict experience of dentinal caries 3 years later or the experience of restorative treatment (not re-treatment) during the 3-year period. The data was derived from a prospective 3-year longitudinal study in which the dental care provided by 41 dentists for 403 adolescents was monitored. Dental caries experience was monitored by annual standardised assessments of caries undertaken by a single trained examiner. ROC analysis showed that caries assessed visually at the D1 threshold in 12-year-olds was a better predictor (P < 0.001) of experiencing some dentinal caries after 3 years (Az = 0.781) than was caries assessed visually at D3 threshold in 12-year-olds (Az = 0.670). Assessing caries visually at either the D1 or the D3 threshold had no discriminatory power for predicting whether an individual would experience some restorative treatment during the ensuing 3-year period (Az for D1 = 0.507; Az for D3 = 0.518).

Community-based education programs in Africa: faculty experience within the Medical Education Partnership Initiative (MEPI) network.

PURPOSE: This paper examines the various models, challenges, and evaluative efforts of community-based education (CBE) programs at Medical Education Partnership Initiative (MEPI) schools and makes recommendations to strengthen those programs in the African context. METHODS: Data were gathered from 12 MEPI schools through self-completion of a standardized questionnaire on goals, activities, challenges, and evaluation of CBE programs over the study period, from November to December 2013. Data were analyzed manually through the collation of inputs from the schools included in the survey. RESULTS: CBE programs are a major component of the curricula of the surveyed schools. CBE experiences are used in sensitizing students to community health problems, attracting them to rural primary health care practice, and preparing them to perform effectively within health systems. All schools reported a number of challenges in meeting the demands of increased student enrollment. Planned strategies used to tackle these challenges include motivating faculty, deploying students across expanded centers, and adopting innovations. In most cases, evaluation of CBE was limited to assessment of student performance and program processes. CONCLUSIONS: Although the CBE programs have similar goals, their strategies for achieving these goals vary. To identify approaches that successfully address the challenges, particularly with increasing enrollment, medical schools need to develop structured models and tools for evaluating the processes, outcomes, and impacts of CBE programs. Such efforts should be accompanied by training faculty and embracing technology, improving curricula, and using global/regional networking opportunities.

Time to treatment and patient outcomes among TB suspects screened by a single point-of-care xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa.

INTRODUCTION: In December 2010, the World Health Organization recommended a single Xpert MTB/RIF assay as the initial diagnostic in people suspected of HIV-associated or drug resistant tuberculosis. Few data are available on the impact of this recommendation on patient outcomes. We describe the diagnostic follow-up, clinical characteristics and outcomes of a cohort of tuberculosis suspects screened using a single point-of-care Xpert. METHODS: Consecutive tuberculosis suspects at a primary care clinic in Johannesburg, South Africa were assessed for tuberculosis using point-of-care Xpert. Sputum smear microscopy and liquid culture were performed as reference standards. Xpert-negatives were evaluated clinically, and further assessed at the discretion of clinicians. Participants were followed for six months. RESULTS: From July-September 2011, 641 tuberculosis suspects were enrolled, of whom 69% were HIV-infected. Eight percent were positive by a single Xpert. Among 116 individuals diagnosed with TB, 66 (57%) were Xpert negative, of which 44 (67%) were empirical or radiological diagnoses and 22 (33%) were Xpert negative/culture-positive. The median time to tuberculosis treatment was 0 days (IQR: 0-0) for Xpert positives, 14 days (IQR: 5-35) for those diagnosed empirically, 14 days (IQR: 7-29) for radiological diagnoses, and 144 days (IQR: 28-180) for culture positives. Xpert negative tuberculosis cases were clinically similar to Xpert positives, including HIV status and CD4 count, and had similar treatment outcomes including mortality and time to antiretroviral treatment initiation. CONCLUSIONS: In a high HIV-burden setting, a single Xpert identified less than half of those started on tuberculosis treatment, highlighting the complexity of TB diagnosis even in the Xpert era. Xpert at point-of-care resulted in same day treatment initiation in Xpert-positives, but had no impact on tuberculosis treatment outcomes or mortality.