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AIMS: This research synthesis protocol addresses the question: what is the evidence concerning measurement properties of dental patient reported outcome measures (dPROMs), and regarding the real-world value of dPROMs, and where are the gaps in this evidence? Evidence mapping will systematically examine reviews of quantitative dPROMs used to assess the impact of oral health on the quality of life of dental patients and research participants. Evidence gaps where future research or systematic reviews are required will be identified. MATERIALS AND METHODS: This protocol accords with the PRISMA-P guideline. Open Science Framework Registration https://doi.org/10.17605/OSF.IO/RZD3N . Biomedical and grey literature databases will be searched, adapting the same search strategy. Published or unpublished reviews evaluating any dPROM will be considered for inclusion. There will be no restriction by date, setting, or language. AMSTAR2 and ROBIS will evaluate risk of bias. Psychometric criteria will be adapted from COSMIN. Data will be summarised separately for specific populations and conditions. DISCUSSION: The findings will enable clinicians and researchers to identify methodologically robust dPROMs, appropriate for use with relevant populations and conditions. Implications for real-world practice and research will be discussed.
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Background: The prevalence of overweight and obesity among children may have reached a plateau in some developed countries, including Ireland. The aim of this study was to examine 12-year trends in the prevalence of overweight and obesity among primary-school-aged children in the Republic of Ireland between 2002 and 2014. Methods: Two large-scale oral health cross-sectional surveys of primary-school-aged children aged 4-13 years were conducted 12 years apart in 2002 (n=14,055; response rate=68%) and 2014 (n=5,223; response rate=67%). Both surveys included standardised and calibrated height and weight measures. Ownership of a means-tested medical card determined economic status. Standard International Obesity Task Force criteria were applied to determine the prevalence of overweight and obesity. Results: The overall prevalence of overweight/obesity among 4-13-year-olds significantly decreased from 26% (95% CI: 25.1%-26.5%) in 2002 to 24% (95% CI: 22.4%-24.7%) in 2014. Among boys and girls aged 4-13 years, the significant decrease was from 23% (95% CI: 22.1%-24.1%) to 20% (95% CI: 18.9%-22.0 and 28% (95% CI: 27.4%-29.5%) to 27% (95% CI: 25.0%-28.4%), respectively. Among 5-year-old children, the overall prevalence of overweight and obesity significantly decreased from 25% (95% CI: 23.7%-26.2%) to 22% (95% CI: 19.9%-23.4%). In 2002, the estimated prevalence of overweight/obesity was similar in children with and without medical cards, whereas in 2014, overall prevalence was higher in those with medical cards. Conclusions: Results suggest a fall in the prevalence of overweight/obesity between 2002 and 2014, and may suggest a favourable cohort effect. Despite this fall, the overall prevalence remains high and socioeconomic disparities have increased.
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Background: The reduction in dental caries seen between Irish national surveys of children's oral health in 1984 and 2002 was accompanied by an increase in the prevalence of enamel fluorosis. To minimise the risk of enamel fluorosis in Irish children, in 2007, the level of fluoride in drinking water was reduced from 0.8-1.0 ppm to 0.6-0.8 ppm fluoride. Recommendations on the use of fluoride toothpastes in young children were issued in 2002. Fluoride and Caring for Children's Teeth (FACCT) is a collaborative project between the Oral Health Services Research Centre, University College Cork and the Health Service Executive dental service, with funding from the Health Research Board. Aim: FACCT aims to evaluate the impact and the outcome of the change in community water fluoridation (CWF) policy (2007) on dental caries and enamel fluorosis in Irish schoolchildren, while also considering the change in policy on the use of fluoride toothpastes (2002). Methods/Design: A cross-sectional study with nested longitudinal study will be conducted in school year (SY) 2013-2014 by trained and calibrated dental examiners in primary schools in counties Dublin, Cork and Kerry for a representative sample of children born either prior to or post policy changes; age 12 (born 2001) and age 5, (born 2008). Five-year-olds will be followed-up when they are 8-year-olds (SY 2016-2017). The main explanatory variable will be fluoridation status of the children (lifetime exposure to CWF yes/no). Information about other explanatory variables will be collected via parent (of 5-, 8- and 12-year-olds) and child completed (8- and 12-year-olds only) questionnaires. The main outcomes will be dental caries (dmf/DMF Index), enamel fluorosis (Dean's Index) and oral health-related quality of life (OHRQoL). Multivariate regression analyses will be used to determine the impact and outcome of the change in CWF policy on oral health outcomes controlling for other explanatory variables.
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BACKGROUND: Dental plaque associated gingivitis is a reversible inflammatory condition caused by accumulation and persistence of microbial biofilms (dental plaque) on the teeth. It is characterised by redness and swelling of the gingivae (gums) and a tendency for the gingivae to bleed easily. In susceptible individuals, gingivitis may lead to periodontitis and loss of the soft tissue and bony support for the tooth. It is thought that chlorhexidine mouthrinse may reduce the build-up of plaque thereby reducing gingivitis. OBJECTIVES: To assess the effectiveness of chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for the control of gingivitis and plaque compared to mechanical oral hygiene procedures alone or mechanical oral hygiene procedures plus placebo/control mouthrinse. Mechanical oral hygiene procedures were toothbrushing with/without the use of dental floss or interdental cleaning aids and could include professional tooth cleaning/periodontal treatment.To determine whether the effect of chlorhexidine mouthrinse is influenced by chlorhexidine concentration, or frequency of rinsing (once/day versus twice/day).To report and describe any adverse effects associated with chlorhexidine mouthrinse use from included trials. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 28 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8) in the Cochrane Library (searched 28 September 2016); MEDLINE Ovid (1946 to 28 September 2016); Embase Ovid (1980 to 28 September 2016); and CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 28 September 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials assessing the effects of chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for at least 4 weeks on gingivitis in children and adults. Mechanical oral hygiene procedures were toothbrushing with/without use of dental floss or interdental cleaning aids and could include professional tooth cleaning/periodontal treatment. We included trials where participants had gingivitis or periodontitis, where participants were healthy and where some or all participants had medical conditions or special care needs. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results extracted data and assessed the risk of bias of the included studies. We attempted to contact study authors for missing data or clarification where feasible. For continuous outcomes, we used means and standard deviations to obtain the mean difference (MD) and 95% confidence interval (CI). We combined MDs where studies used the same scale and standardised mean differences (SMDs) where studies used different scales. For dichotomous outcomes, we reported risk ratios (RR) and 95% CIs. Due to anticipated heterogeneity we used random-effects models for all meta-analyses. MAIN RESULTS: We included 51 studies that analysed a total of 5345 participants. One study was assessed as being at unclear risk of bias, with the remaining 50 being at high risk of bias, however, this did not affect the quality assessments for gingivitis and plaque as we believe that further research is very unlikely to change our confidence in the estimate of effect. Gingivitis After 4 to 6 weeks of use, chlorhexidine mouthrinse reduced gingivitis (Gingival Index (GI) 0 to 3 scale) by 0.21 (95% CI 0.11 to 0.31) compared to placebo, control or no mouthrinse (10 trials, 805 participants with mild gingival inflammation (mean score 1 on the GI scale) analysed, high-quality evidence). A similar effect size was found for reducing gingivitis at 6 months. There were insufficient data to determine the reduction in gingivitis associated with chlorhexidine mouthrinse use in individuals with mean GI scores of 1.1 to 3 (moderate or severe levels of gingival inflammation). Plaque Plaque was measured by different indices and the SMD at 4 to 6 weeks was 1.45 (95% CI 1.00 to 1.90) standard deviations lower in the chlorhexidine group (12 trials, 950 participants analysed, high-quality evidence), indicating a large reduction in plaque. A similar large reduction was found for chlorhexidine mouthrinse use at 6 months. Extrinsic tooth staining There was a large increase in extrinsic tooth staining in participants using chlorhexidine mouthrinse at 4 to 6 weeks. The SMD was 1.07 (95% CI 0.80 to 1.34) standard deviations higher (eight trials, 415 participants analysed, moderate-quality evidence) in the chlorhexidine mouthrinse group. There was also a large increase in extrinsic tooth staining in participants using chlorhexidine mouthrinse at 7 to 12 weeks and 6 months. Calculus Results for the effect of chlorhexidine mouthrinse on calculus formation were inconclusive. Effect of concentration and frequency of rinsing There were insufficient data to determine whether there was a difference in effect for either chlorhexidine concentration or frequency of rinsing. Other adverse effects The adverse effects most commonly reported in the included studies were taste disturbance/alteration (reported in 11 studies), effects on the oral mucosa including soreness, irritation, mild desquamation and mucosal ulceration/erosions (reported in 13 studies) and a general burning sensation or a burning tongue or both (reported in nine studies). AUTHORS' CONCLUSIONS: There is high-quality evidence from studies that reported the Löe and Silness Gingival Index of a reduction in gingivitis in individuals with mild gingival inflammation on average (mean score of 1 on the 0 to 3 GI scale) that was not considered to be clinically relevant. There is high-quality evidence of a large reduction in dental plaque with chlorhexidine mouthrinse used as an adjunct to mechanical oral hygiene procedures for 4 to 6 weeks and 6 months. There is no evidence that one concentration of chlorhexidine rinse is more effective than another. There is insufficient evidence to determine the reduction in gingivitis associated with chlorhexidine mouthrinse use in individuals with mean GI scores of 1.1 to 3 indicating moderate or severe levels of gingival inflammation. Rinsing with chlorhexidine mouthrinse for 4 weeks or longer causes extrinsic tooth staining. In addition, other adverse effects such as calculus build up, transient taste disturbance and effects on the oral mucosa were reported in the included studies.
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Clorhexidina/uso terapéutico , Placa Dental/tratamiento farmacológico , Gingivitis/tratamiento farmacológico , Antisépticos Bucales/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia Adyuvante , Niño , Clorhexidina/efectos adversos , Placa Dental/complicaciones , Índice de Placa Dental , Profilaxis Dental , Femenino , Gingivitis/etiología , Humanos , Masculino , Persona de Mediana Edad , Antisépticos Bucales/efectos adversos , Higiene Bucal , Sesgo de Publicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Decoloración de Dientes/inducido químicamenteRESUMEN
OBJECTIVES: To provide a broad overview of methodological issues in the design and evaluation of intervention studies in dental public health, with particular emphasis on explanatory trials, pragmatic trials and complex interventions. METHODS: We present a narrative summary of selected publications from the literature outlining both historical and recent challenges in the design and evaluation of intervention studies and describe some recent tools that may help researchers to address these challenges. RESULTS: It is now recognised that few intervention studies in dental public health are purely explanatory or pragmatic. We describe the PRECIS tool which can be used by trialists to assess and display the position of their trial on a continuum between the extremes of explanatory and pragmatic trials. The tool aims to help trialists make design decisions that are in line with their stated aims. The increasingly complex nature of dental public health interventions presents particular design and evaluation challenges. The revised Medical Research Council (MRC) guidance for the development and evaluation of complex interventions which emphasises the importance of planning and process evaluation is a welcome development. We briefly describe the MRC guidance and outline some examples of complex interventions in the field of oral health. The role of observational studies in monitoring public health interventions when the conduct of RCTs is not appropriate or feasible is acknowledged. We describe the STROBE statement and outline the implications of the STROBE guidelines for dental public health. CONCLUSION: The methodological challenges in the design, conduct and reporting of intervention studies in oral health are considerable. The need to provide reliable evidence to support innovative new strategies in oral health policy is a major impetus in these fields. No doubt the 'Methodological Issues in Oral Health Research' group will have further opportunities to highlight this work.
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Investigación Dental/métodos , Proyectos de Investigación , Ensayos Clínicos como Asunto/normas , Métodos Epidemiológicos , Humanos , Salud BucalRESUMEN
AIMS: Our purpose was to systematically review the literature on the effectiveness of chlorhexidine varnish for preventing dental caries in children and adolescents and to determine its effectiveness compared to fluoride varnish. METHODS: MEDLINE, EMBASE and the Cochrane Library were searched through December 2009 to identify relevant randomised trials with blind outcome assessment and a minimum duration of 1 year. The search was later updated in MEDLINE and the Cochrane Library to March 19th, 2010. Risk of bias of the included trials was assessed. The primary outcome was the caries increment. RESULTS: Twelve trials met the inclusion criteria for the review. There was considerable variation between trials in the concentration and frequency of application of the chlorhexidine varnish, in baseline caries levels and in background exposure to fluoride. Six parallel-group trials reported no statistically significant difference in caries increment in permanent teeth with the application of chlorhexidine varnish compared to placebo or no treatment. The results of 4 split-mouth trials were conflicting: 2 trials found no significant difference in caries increment and 2 reported statistically significant results in favour of chlorhexidine varnish. One trial of the effect of chlorhexidine varnish in primary teeth demonstrated a statistically significant reduction in caries increment. The results of 1 trial comparing chlorhexidine varnish with fluoride varnish for preventing caries in adolescents were equivocal. CONCLUSION: Evidence regarding the effectiveness of chlorhexidine varnish for preventing caries is inconclusive. Further well-conducted randomised trials are required before chlorhexidine varnish can be recommended for caries prevention.