Search

BackgroundHistorically, 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.ObjectivesThe 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.DesignThis 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.SettingThis trial was set in primary dental care in Scotland, England and Wales.ParticipantsParticipants 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.InterventionsThree 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 measuresThe 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.ResultsA 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.ConclusionsThere 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 workRecommendations 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 registrationCurrent Controlled Trials ISRCTN77044005.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 24, No. 1. See the NIHR Journals Library website for further project information.

Background Dental caries is one of the most common chronic diseases of childhood and is associated with adverse health and economic consequences for infants and their families. Socioeconomically disadvantaged children have a higher risk of early childhood caries (ECC). Objectives To assess the effects of interventions with pregnant women, new mothers or other primary caregivers of infants in the first year of life, for preventing ECC (from birth to six years of age). Search methods Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 14 January 2019), Cochrane Pregnancy and Childbirth Group's Trials Register (to 22 January 2019), Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Register of Studies, to 14 January 2019), MEDLINE Ovid (1946 to 14 January 2019), Embase Ovid (1980 to 14 January 2019) and CINAHL EBSCO (1937 to 14 January 2019). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on language or publication status. Selection criteria Randomised controlled trials (RCTs) comparing one or more interventions with pregnant women, mothers, or other caregivers of infants in the first year of life (intervention types included clinical, oral health education/promotion such as hygiene education, breastfeeding and other dietary advice, and policy or health service), versus standard care or placebo or another intervention. For inclusion, trials had to report at least one caries outcome. Data collection and analysis Two review authors independently assessed trial eligibility, extracted data, assessed risk of bias, and assessed certainty of evidence using the GRADE approach. Main results We included 17 RCTs (4 cluster-randomised), involving 23,732 caregivers (mainly mothers) and their children. Eleven RCTs assessed four oral health education/promotion interventions against standard care: child diet advice, child diet and feeding practice advice, breastfeeding promotion and support, and oral hygiene with child diet and feeding practice advice. Six trials assessed clinical interventions in mother's dentition, four trials chlorhexidine (CHX, a commonly prescribed antiseptic agent) or iodine-NaF application and prophylaxis versus placebo, and two trials xylitol against CHX or CHX + xylitol. At most, three trials (maximum of 1148 children and 130 mothers) contributed data to any comparison. For many trials, risk of bias was judged unclear due to lack of methodological details reported, and there was high risk of attrition bias in some trials. None of the included trials indicated receiving funding that is likely to have influenced their results. The trials were performed in high-, middle- and low-income countries. In nine trials, participants were socioeconomically disadvantaged. For child diet and feeding practice advice versus standard care, we observed a probable 15 per cent reduced risk of caries presence in primary teeth with the intervention (RR 0.85, 95% CI 0.75 to 0.97; 3 trials; 782 participants; moderate-certainty evidence), and there may be a lower mean dmfs (decayed, missing, filled primary surfaces) score (MD -0.29, 95% CI -0.58 to 0; 2 trials; 757 participants; low-certainty evidence); however, we are uncertain regarding the difference between the groups in mean dmft (decayed, missing, filled teeth) score (MD -0.90, 95% CI -1.85 to 0.05; 1 trial; 340 participants; very low-certainty evidence). For breastfeeding promotion and support versus standard care, we observed that there may be little or no a difference between groups in the risk of caries presence in primary teeth (RR 0.96, 95% CI 0.89 to 1.03; 2 trials; 1148 participants; low-certainty evidence), or mean dmft score (MD -0.12, 95% CI -0.59 to 0.36; 2 trials; 652 participants; low-certainty evidence). Dmfs was not reported for this comparison. We are uncertain whether child diet advice only compared with standard care reduces risk of caries presence in primary teeth (RR 1.08, 95% CI 0.34 to 3.37; 1 trial; 148 participants; very low-certainty evidence). Dmfs and dmft were not reported for this comparison. For oral hygiene, child diet and feeding practice advice versus standard care, we observed little or no reduced risk of caries presence in primary teeth (RR 0.91, 95% CI 0.75 to 1.10; 2 trials; 365 participants; low-certainty evidence), and are uncertain regarding difference between the groups in mean dmfs score (MD -0.99, 95% CI -2.45 to 0.47; 1 trial; 187 participants; very low-certainty evidence) and dmft score (MD -0.30, 95% CI -0.96 to 0.36; 1 trial; 187 participants; very low-certainty evidence). We observed there may be little or no difference in risk of caries presence in primary teeth between antimicrobial and placebo treatment in mother's dentition (RR 0.97, 95% CI 0.80 to 1.19; 3 trials; 479 participants; very low-certainty evidence). No trials assessing this comparison reported dmfs or dmft. For xylitol compared with CHX antimicrobial treatment, we observed there may be a lower mean dmft score with xylitol (MD -2.39; 95% CI -4.10 to -0.68; 1 trial, 113 participants; low-certainty evidence); however, we are uncertain regarding the difference between groups in caries presence in primary teeth (RR 0.62, 95% CI 0.27 to 1.39; 1 trial, 96 participants; very low-certainty evidence). Neither trial evaluating this comparison reported dmfs. No trials assessed a health policy or service intervention. Authors' conclusions Moderate-certainty evidence suggests that providing advice on diet and feeding to pregnant women, mothers or other caregivers with children up to the age of one year probably leads to a slightly reduced risk of early childhood caries (ECC). The remaining evidence is low to very low certainty and is insufficient for determining which, if any, other interventions types and features may be effective for preventing ECC. Large, high-quality RCTs of oral health education/promotion, clinical, and policy and service access interventions, are warranted to determine effects and relative effects of different interventions and inform practice. We have identified 12 studies currently in progress. Those designing future studies should describe the intervention components, setting and participants, consider if and how effects are modified by intervention features and participant characteristics, and adopt a consistent approach to measuring and reporting ECC.

Objective To assess the prevalence and severity of dental fluorosis and caries among Malaysian children following the reduction in fluoride concentration from 0.7 to 0.5 parts per million (ppm) in the public water supply. Methods This study involved lifelong residents aged 9‐ and 12‐year‐olds in fluoridated and nonfluoridated areas in Malaysia (n = 1155). In the fluoridated area, children aged 12 years and 9 years were exposed to 0.7 and 0.5 ppm, respectively, at the times when maxillary central incisors developed. Standardized photographs of maxillary central incisors were blind scored for fluorosis using Dean's criteria. Dental caries was examined using ICDAS‐II criteria. Results The prevalence of fluorosis (Dean's score ≥ 2) among children in the fluoridated area (35.7%, 95% CI: 31.9%‐39.6%) was significantly higher (P < 0.001) than children in the nonfluoridated area (5.5%, 95% CI: 3.6%‐7.4%). Of those in the fluoridated area, the prevalence of fluorosis decreased from 38.4% (95% CI: 33.1%‐44.3%) for 12‐year‐olds to 31.9% (95% CI: 27.6%‐38.2%) for 9‐year‐olds, although this difference was not statistically significant (P = 0.139). The mean caries experience in the permanent dentition was significantly lower in the fluoridated area than in the nonfluoridated area for both age groups (P < 0.05). In the multivariate models, the difference in the differences of caries experience between fluoridated and nonfluoridated areas remained statistically significant. This suggests that caries‐preventive effect is still maintained at 0.5 ppm. Conclusion Findings indicate that the change in fluoride level from 0.7 to 0.5 ppm has reduced fluorosis and maintains a caries‐preventive effect. Although there is a reduction in fluorosis prevalence, the difference was not statistically significant.

Aim: The aim of this study was to review patterns of restoration placement and replacement. A previous study had been carried out in the late 1990s and this study sought to update the literature in this important aspect of dental practice. Method: Studies based on the protocol of Mjör (1981) were selected. Such studies involved participating dentists completing a proforma each time a patient presented for a new or replacement restoration. Results: Twenty-five papers were included in this study, of which 12 were included in the original review. The pre-1998 review reported on the placement of 32,697 restorations, of which 14,391 (44%) were initial placements and 18,306 (56%) were replacements. The new studies included in the post-1998 review reported on an additional 54,023 restorations, of which 22,625 (41.9%) were initial placements and 31,398 (58.1%) were replacements. Therefore, across all studies considered, information is available on 86,720 restorations, of which 37,016 (42.7%) were new placements and 49,704 (57.3%) were replacements. Comparing review periods, there was a reduction in the placement of amalgam restorations from 56.7% (pre-1998 review) to 31.2% (post-1998 review), with a corresponding increase in the placement of resin composites from 36.7% to 48.5%. The most common use of amalgam was seen in Nigeria (71% of restorations), Jordan (59% of restorations) and the UK (47% of restorations). The most frequent use of resin composite was seen in Australia (55% of restorations), Iceland (53% of restorations) and Scandinavia (52% of restorations). Secondary caries was the most common reason for replacing restorations (up to 59% of replacement restorations). Conclusion: In the years subsequent to the initial review, replacement of restorations still accounts for more than half of restorations placed by dentists, and the proportion of replacement restorations continues to increase. Trends towards the increased use of resin composites is noted in recent years. Clinical significance: Further research is required in this area to investigate changes in the approaches to the restoration of teeth, especially with increased understanding of the concept of restoration repair as an alternate to replacement.

Fissure sealant (FS) and fluoride varnish (FV) are effective in preventing dental caries when compared with a no-treatment control. However, the relative clinical effectiveness of these interventions is uncertain. The objective of the study was to compare the clinical effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- to 7-y-olds. The study design was a randomized clinical trial, with 2 parallel arms. The setting was a targeted-population program that used mobile dental clinics in schools located within areas of high social and economic deprivation in South Wales. A total of 1,016 children were randomized 1:1 to receive either FS or FV. Resin-based FS was applied to caries-free FPMs and maintained at 6-mo intervals. FV was applied at baseline and at 6-mo intervals for 3 y. The main outcome measures were the proportion of children developing caries into dentine (D4-6MFT) on any 1 of up to 4 treated FPMs after 36 mo. At 36 mo, 835 (82%) children remained: 417 in the FS arm and 418 in the FV arm. A smaller proportion of children who received FV (n = 73, 17.5%) versus FS (n = 82, 19.6%) developed caries into dentine on at least 1 FPM (odds ratio [OR] = 0.84; 95% CI, 0.59 to 1.21; P = 0.35), a nonstatistically significant difference between FS and FV treatments. The results were similar when the number of newly decayed teeth (OR = 0.86; 95% CI, 0.60 to 1.22) and tooth surfaces (OR = 0.85; 95% CI, 0.59 to 1.21) were examined. In a community oral health program, semiannual application of FV resulted in caries prevention that was not significantly different from that obtained by applying and maintaining FS after 36 mo (EudraCT: 2010-023476-23; ISRCTN: ISRCTN17029222).

Background The 2013 Children's Dental Health Survey is the fifth in a series of national surveys.\ud \ud Aims To describe caries prevalence and severity and factors affecting these, in children in England, Wales and Northern Ireland in 2013.\ud \ud Methodology A representative sample of children (aged 5, 8, 12 and 15 years) in England, Wales and Northern Ireland were invited to participate in dental examinations. Caries was measured at both the dentine ('obvious caries') and dentine plus enamel ('clinical caries') levels and analysis included identifying those with indicators of significant burden of caries and identifying predictive factors.\ud \ud Results In 5-year-olds, 40% had obvious caries experience increasing to 56% when enamel lesions were included. In 15-year-olds, the respective figures were 46% and 63%. Fourteen percent of 5-year-olds and 15% of 15-year-olds had a least one indicator of significant levels of caries and those from deprived backgrounds were more likely to fall into this group.\ud \ud Conclusions Overall, the prevalence of caries in children is continuing to decrease, but the rate is slowing. The level of disease for those with disease is much higher than the average values might suggest and there remain a sizeable minority with a significant burden of caries, associated with deprivation. This complex picture poses significant clinical and public health challenges.

The Seal or Varnish study is a pragmatic randomised trial to evaluate the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental caries in high-risk children in South Wales. In partnership with the Cardiff & Vale UHB Community Dental Service (CDS), the trial utilises the infrastructure of an existing school-based dental programme to conduct clinical assessments/intervention delivery via mobile dental units. While this research naive setting is novel for a CTIMP, in accordance with the 2012 MRC/DH/MHRA joint guidance for risk-adapted approaches to the management of CTIMPs, the low risk nature of the interventions have allowed justification of several risk-based adaptations to the management and conduct of the trial. In addition, through the use of consultation exercises with a representative parents group, adaptations to the standard NRES templates for participant information sheets/consent forms have also been developed in an attempt to maximise uptake onto the trial. Employment of the risk-adapted approach has minimised additional administrative burden placed on the CDS in implementing the trial compared with the existing dental programme. The adaptations made to the consent process and participant materials have received positive feedback, however consent rates for the trial were found to be lower than previous years' response rates to the dental programme in the majority of schools. This trial represents one of the first experiences of employing a risk-adapted approach to management of CTIMPs, highlighting several areas for consideration when designing and implementing trials involving low-risk interventions in novel environments.