Dataset Information

Validity of sealant retention as surrogate for caries prevention--a systematic review.

ABSTRACT:

Introduction/aim

To appraise the clinical literature in determining whether loss of complete sealant retention as surrogate endpoint is directly associated with caries occurrence on sealed teeth as its clinical endpoint and to apply the appraised evidence in testing the null-hypothesis that the retention/caries ratio between different types of sealant materials (resin and glass-ionomer cement) is not statistically significant (= Prentice criterion for surrogate endpoint validity).

Methods

Databases searched PubMed/Medline, Directory of Open Access Journals; IndMed, Scielo. Systematic reviews were checked for suitable trials. The search terms: "fiss* AND seal*" and "fissure AND sealant" were used. Article selection criteria were: clinical trial reporting on the retention and caries occurrence of resin and/or glass-ionomer cement (GIC) fissure sealed permanent molar teeth; minimum 24-month follow-up period; systematic review or meta-analysis. Datasets and information were extracted from accepted trials. The principle outcome measure was the ratio of Risk of loss of complete retention to the Risk of caries occurrence per sealant type (RCR). Risk of bias was assessed in trials and sensitivity analysis with regard to potential confounding factors conducted. The null-hypothesis was tested by graphical and statistical methods.

Results

The risk of loss of complete retention of sealant materials was associated with the risk of caries occurrence for resin but not for GIC based sealants. The difference between RCR values of the two sealant types was statistically significant (p<0.05). The null-hypothesis was rejected.

Conclusions

The current clinical evidence suggests that complete retention of pit and fissure sealants may not be a valid surrogate endpoint for caries prevention as its clinical endpoint. Further research is required to corroborate the current results.

SUBMITTER: Mickenautsch S

PROVIDER: S-EPMC3806731 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Validity of sealant retention as surrogate for caries prevention--a systematic review.

Mickenautsch Steffen S Yengopal Veerasamy V

PloS one 20131023 10

<h4>Introduction/aim</h4>To appraise the clinical literature in determining whether loss of complete sealant retention as surrogate endpoint is directly associated with caries occurrence on sealed teeth as its clinical endpoint and to apply the appraised evidence in testing the null-hypothesis that the retention/caries ratio between different types of sealant materials (resin and glass-ionomer cement) is not statistically significant (= Prentice criterion for surrogate endpoint validity).<h4>Met ...[more]

PMID: 24194861

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Project description:BackgroundThe relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern China (ClinicalTrials.gov NCT01829334).MethodsAfter obtaining ethical approval, healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study. Included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth. Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods. Fissure status of the molars in each group was evaluated every 6 months. Development of dentine caries and sealant retention over 24 months in the molars in the two sealant-using groups was compared in this report. Outcome on cost-effectiveness of all four groups over 36 months will be reported elsewhere.ResultsAt baseline, a total of 280 children (383 molars) with mean age 7.8 years were involved for the two sealant groups. After 24 months, 261 children (357 molars) were followed. Proportions of molars with dentine caries were 7.3% and 3.9% in the ART sealant and fluoride-releasing resin sealant groups, respectively (chi-square test, p = 0.171). Life-table survival analysis showed that sealant retention (full and partial) rate over 24 months for the resin sealant (73%) was significantly higher than that (50%) for the ART sealant (p < 0.001). Molar survival (no development of dentine caries) rates in the ART sealant (93%) and fluoride-releasing resin sealant (96%) groups were not significantly different (p = 0.169). Multilevel logistic regression (GEE modeling) accounting for the effects of data clustering and confounding factors confirmed this finding.ConclusionsThough the retention of fluoride-releasing resin sealant was better than that of the ART sealant, their effectiveness in preventing fissure caries in permanent molars did not differ significantly over 24 months. ART sealants could be a good alternative when and where resources for resin sealant placement are not readily available.

Project description:Dental caries is still one of the most prevalent diseases worldwide. Research has shown that fluoride has a role in caries prevention. For many reasons there are concerns about young children using fluoride-containing oral care products. Consequently, there is a need to identify effective fluoride-free products. A large body of literature now exists on the use of biomimetic hydroxyapatite (HAP) as an active ingredient in oral care products to combat caries.AimTo conduct a systematic review of the clinical evidence of the effects of HAP-based fluoride-free oral care products in caries reduction and conduct a meta-analysis of available randomized clinical trials (RCTs).MethodsUsing the PICO question "In individuals of all ages (P), do fluoride-free oral care products containing HAP as the anti-caries agent (I), compared to products with fluoride or without caries control products (C), reduce the risk of dental caries (O)?" Ovid MEDLINE (PubMed), Scopus, EMBASE, and Web of Science databases were searched using the following keywords: apatite, hydroxyapatite, caries, dental decay, dentin(e), enamel, toothpaste, dentifrice, mouthwash, gels, biofilm, (dental) plaque, ero(de, ded, sion), (de, re)mineral(ise, ized, ised, ization, isation). Reviews, tooth whitening, tooth sensitivity, and in vitro studies were excluded. PRISMA was used for the search and GRADE was used to assess quality. Clinical trials were subjected to the Cochrane Risk of Bias assessment followed by meta-analysis.Results291 studies were retrieved; 22 were suitable for systematic review, 5 were clinical caries trials and 4 were RCTs. A meta-analysis of 3 RCTs was possible showing HAP provided 17% protection against caries. The other 17 trials had simpler proxy outcomes for anticaries effects. Some trials showed non-inferior performance of HAP products compared to those with fluoride.ConclusionThere is good evidence that hydroxyapatite in oral care products in the absence of fluoride effectively reduces caries.

Project description:Introduction/objectivesThe review systematically explored in vivo or in situ studies investigating the efficacy of nano-hydroxyapatite (nHA) to reduce initiation of or to remineralize initial caries lesions.DataProspective controlled (non-)randomized clinical trials investigating the efficacy of a nHA compared to any other (placebo) treatment or untreated/standard control.SourcesThree electronic databases (Central Cochrane, PubMed-MEDLINE, Ovid EMBASE) were screened. Outcomes were, e.g., ICDAS score, laser fluorescence, enamel remineralization rate, mineral loss, and lesion depth. No language or time restrictions were applied. Risk of bias and level of evidence were graded using the Risk of Bias 2.0 tool and GRADE profiler.Study selection/resultsFive in vivo (and 5 in situ) studies with at least 633 teeth (1031 specimens) being assessed in more than 420 (95) patients were included. No meta-analysis could be performed for in vivo studies due to the high heterogeneity of the study designs and the variety of outcomes. In situ studies indicate that under demineralization conditions, NaF was able to hinder demineralization, whereas nHA did not; simultaneously, nHA did not differ from the fluoride-free control. In contrast, under remineralizing conditions, nHA and NaF show the same remineralizing potential. However, the level of evidence was very low. Furthermore, six studies showed a high risk of bias, and six studies were funded/published by the manufacturers of the tested products.ConclusionThe low number of clinical studies, the relatively short follow-up periods, the high risks of bias, and the limiting grade of evidence do not allow for conclusive evidence on the efficacy of nHA.Clinical relevanceNo conclusive evidence on the efficacy of nHA could be obtained based on the low number of clinical studies, the relatively short follow-up periods, the high risks of bias, the limiting grade of evidence, and study conditions that do not reflect the everyday conditions.

Dataset Information

Validity of sealant retention as surrogate for caries prevention--a systematic review.

Introduction/aim

Methods

Results

Conclusions

Publications

Validity of sealant retention as surrogate for caries prevention--a systematic review.

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