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DOI: 10.1055/s-0045-1814727
Evaluation of Clinical Performance of Moisture-tolerant Sealant on Pit and Fissure Caries in Two Different Setting Conditions: A Randomized Controlled Trial
Authors
Funding The authors have received financial support for the research, authorship and/or publication of this article from Nims University, Jaipur, Rajasthan, India.
Abstract
Objective
The moisture-tolerant resin-based sealant Embrace WetBond (EWB), designed for effective bonding in moist conditions, offers a promising solution for caries prevention in challenging clinical environments. This study aimed to evaluate and compare its retention rate and caries-preventive efficacy in newly erupted permanent molars under two distinct clinical settings.
Materials and Methods
This split-mouth randomized controlled trial assessed EWB sealant under moisture-controlled and non-moisture-controlled conditions in schoolchildren aged 6 to 14 years with bilateral, non-cavitated molars. A total of 37 participants (112 teeth; 56 per group) were randomized, each serving as their own control. Sealant retention, caries prevention, marginal discoloration, marginal adaptation, color match, and smoothness of surface were assessed at 1, 6, and 12 months using modified USPHS criteria. Statistical analysis included the chi-square test, Mann-Whitney U test, and Friedman test to compare retention rates and sealant performance over time.
Results
A total of 37 children (56 teeth per group) were included, with balanced baseline characteristics due to the split-mouth design. At 12 months, sealant retention significantly declined in both groups (Group I: 96.4% at 1 month to 49% at 12 months; Group II: 96.4 to 54.9%; p < 0.001), though no significant differences were observed between groups (p > 0.05). Caries incidence was minimal, with only 2% of teeth affected at 12 months in each group. Apart from retention, no other parameters showed significant deterioration over 12 months.
Conclusion
Pit and fissure sealants demonstrated similar effectiveness in preventing occlusal caries under both moisture-controlled and non-moisture-controlled conditions over 12 months. Their comparable performance in limited moisture-controlled settings highlights their suitability for real-world clinical practice and public health programs.
Data Availability Statement
All relevant data are included in the manuscript, and additional data, if required, can be provided upon request.
CTRI Registration Number
CTRI/2024/06/068418.
Ethical Approval
The study was performed in accordance with Good Clinical Practice guidelines and conformed to the Declaration of Helsinki. Ethical approval was obtained from the Institutional Ethical Committee before the conduct of the study (IEC Number: IEC/P-260/2023).
Informed Consent
Participants' consent has been obtained from the parents or guardians of school children in a written format.
Publication History
Article published online:
22 January 2026
© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Thieme Medical and Scientific Publishers Pvt. Ltd.
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