NCT02589743

Randomized Clinical Trial of Occlusal Sealant

Impact of the Intermediary Layer on Sealant Retention: A Randomized 24-month Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	Sealant	Application of preventive agent
DEVICE	Adhesive and Sealant	Application of preventive agent and technique for control moisture

Timeline

• Start date: 2003-04-01
• Primary completion: 2003-06-01
• Completion: 2005-06-01
• First posted: 2015-10-28
• Last updated: 2015-10-28