Randomized Clinical Trial of Occlusal Sealant

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Device: Adhesive and Sealant; Device: Sealant

• Registration Number: NCT02589743
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.

Detailed Description

The greatest risk of sealant failure occurs soon after tooth eruption, when contamination with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer between humidity contaminated enamel and sealant can improve bond strength, reduces microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer beneath the sealant seems to be based on a combination of moisture-chasing effects of the hydrophilic primer, increased flow dispersion imparted by the less viscous primer and adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin complex once reaction is complete.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-06
• Study Completion: 2005-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-17
• Study First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Study First Posted: 2015-10-28
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.

Exclusion Criteria

• Carious or absence first molar permanent teeth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Bond and F (Adhesive and Sealant)	Adhesive and Sealant	Pit and fissure sealing using adhesive and sealant
Excite and H (Adhesive and Sealant)	Adhesive and Sealant	Pit and fissure sealing using adhesive and sealant
Helioseal Clear Chroma - H (Sealant)	Sealant	Pit and fissure sealing using only sealant
Fluroshield - F (Sealant)	Sealant	Pit and fissure sealing using only sealant

Primary Outcome Measures

Name	Time	Method
Sealant retention and prevention of dental caries assessed by defined clinical scoring system	6-mouth	Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)