Validity of sealant retention as surrogate for caries prevention – a systematic review [protocol]

REVIEW QUESTION: The objective of this quantitative systematic review is to appraise the current clinical literature for evidence whether loss of complete sealant retention is directly associated with caries occurrence on formerly sealed teeth and to apply the appraised evidence as test for the null-hypothesis that the retention/caries ratio between different types of sealant materials is not statistically significant.

SYSTEMATIC LITERATURE SEARCH: The following electronic databases will be searched by two reviewers (SM and VY), independently: PubMed/Medline, Directory of Open Access Journals (DOAJ); IndMed and Scielo using Systematic reviews, if found of importance to the topic, will be checked for suitable trials.

SEARCH TERM DEVELOPMENT: The string of search terms: “fiss* AND seal*” will be used for database search.

ARTICLE SELECTION CRITERIA: Clinical study reporting on the retention and caries occurrence of resin and/or glass-ionomer cement (GIC) fissure sealed permanent molar teeth (no distinction will be made between different types of resin-based sealants or conventional and resin-modified GIC); Minimum 24-month follow-up period.

DATA EXTRACTION: Besides general trial information the following data will be extracted: N = Number of evaluated sealed teeth; nR = Number of teeth without completely retained fissure sealants - loss of complete material retention, considered as the ‘surrogate endpoint’; nC = Number of sealed teeth with carious lesion/cavities - considered as the ‘clinical endpoint’ - per type of sealant material (Resin/GIC) at the end of each follow-up period.

DATA ANALYSIS AND REPORTING: The principle outcome measure will be the ratio of Risk of loss of complete retention (RR= nR/N) to the Risk of caries occurrence on formally sealed teeth (RC= nC/N) per sealant type (RR/RC ratio). Simple linear regression analysis will be conducted in order to quantify the association between loss of complete retention and carious lesion/cavity development, separately for sealant type. Mann-Whitney U test will be used to test the null-hypothesis that the difference in the RR/RC ratio between the different types of sealant materials is not statistically significant. Risk of bias will be assessed. Sensitivity analysis will be conducted, in regard to any factor assumed to have confounding influence on the obtained results. The completed systematic review report will be submitted as manuscript to a peer-reviewed journal in English language.