Validity of Sealant Retention as Surrogate for Caries Prevention – A Systematic Review

Abstract

Introduction/AimTo 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).MethodsDatabases 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.ResultsThe 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.ConclusionsThe 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.

3-year survival rates of retained composite resin and ART sealants using two assessment criteria

“…To what extent the retention of a sealant is a prerequisite for its preventive effect has not been reported frequently. 5,35,36 In the present study, 84% of the occlusal surfaces sealed with CR and 92% of those sealed according to ART were either partially or completely re-exposed after 3 years while in only approximately 9% of the sealed occlusal surfaces did a cavitated dentine carious lesion develop during the 3-year study period. 14 This indicates that loss of sealant material does not appear to be an indicator for the development of cavitated dentine carious lesions in re-exposed occlusal surfaces.…”

“…Therefore, sealant retention can only be considered a surrogate endpoint and, perhaps, should not be considered an endpoint at all, as was advocated recently. 5 Another remarkable observation was that, although only occlusal surfaces in first permanent molars at high-caries risk were sealed, the level of caries risk in these molars, and perhaps in the mouth, probably became substantially lower over the study years. Whether this is due to the placement of the sealants (despite the low retention over the final evaluated intervals) or to the improved oral health habits of the children over the years is difficult to say.…”

“…3 Currently, the main materials used for sealing pits and fissures are resin-and glass-ionomer-based. 4,5 Retention of sealants is considered a surrogate endpoint for determining the caries-preventive effectiveness of sealants since it is believed that loss of retention would determine sealant failure. However, obtaining a real clinical endpoint by comparing sealed and Declaration of Interests: The authors certify that they have no commercial or associative interest that represents a conflict of interest in connection with the manuscript.…”

“…5,6 Resin-based sealants usually present higher retention rates than glass-ionomer (GIC) based sealants. 6 Despite differences in their retention, systematic reviews have reported no evidence of caries-preventive superiority of either material.…”

Answer to the letter “Complete clinical retention of sealant materials should not be contemplated as cut-off for clinical success”. Braz Oral Res. 2016;30:e32. doi: 10.1590/1807-3107BOR-2016.vol30.0032

“…We actually agree with you that retention of sealant materials cannot be contemplated as any cut-off for clinical success regarding caries prevention; therefore we would like to apologize for our mistake as we erroneously state, "the complete clinical retention of sealant materials should be contemplated as the cutoff for clinical success" and cite your paper as reference to support it. 1 Although we acknowledge that the prevention/arrestment of caries is the most important clinical outcome, other parameters should also be considered when selecting a dental material. The properties required of an ideal pit and fissure sealant include anticariogenicity, biocompatibility, good marginal integrity and retention rate.…”