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Wear Resistance Of Bioactive With And Without Etching Vs. Conventional Resin-Based Fissure Sealants

NCT07018141 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-06-12

No results posted yet for this study

Summary

This randomized clinical trial aimed to compare the wear resistance and clinical performance of bioactive versus conventional resin-based pit and fissure sealants over a 12-month period. Conducted on young adults with sound, caries-susceptible molars, the study evaluated three groups: bioactive sealants applied with and without etching, and conventional resin-based sealants with etching. Clinical assessments and 3D digital scans were used to measure sealant retention and wear. The study seeks to determine whether bioactive sealants, especially when applied without etching, provide comparable long-term protection and durability to conventional sealants, potentially simplifying application without compromising effectiveness.

Conditions

  • Pit and Fissure Caries

Interventions

OTHER

Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp

This group received BeautiSealant (a bioactive giomer-based sealant) applied after etching the enamel surface with 37% phosphoric acid for 15 seconds. The etching process creates micro-retentive patterns in the enamel to enhance micromechanical bonding, potentially improving the sealant's retention and wear resistance while also benefiting from the bioactive material's fluoride release and enamel remineralization properties.

OTHER

Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti

In this group, BeautiSealant was applied directly to the tooth surface without prior etching. The goal was to simplify the procedure by eliminating the etching step, relying instead on the sealant's chemical bonding and bioactive properties (such as fluoride release and S-PRG technology) to maintain retention and resist wear, while reducing the risk of enamel alteration and improving clinical efficiency.

OTHER

Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the trad

This group served as the control and received Fisseal (a conventional resin-based sealant) applied following standard etching with 37% phosphoric acid. This method is considered the gold standard for fissure sealing, offering strong micromechanical adhesion and proven wear resistance, making it a reliable benchmark for evaluating the performance of newer bioactive materials.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2025-09-30
Completion
2026-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018141 on ClinicalTrials.gov