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NCT02589743 Clinical Trial

Randomized Clinical Trial of Occlusal Sealant

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02589743
Other study ID # 1
Secondary ID
Status Completed
Phase Phase 2
First received October 17, 2015
Last updated October 27, 2015
Start date April 2003
Est. completion date June 2005

Study information
Verified date October 2015
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date June 2005
Est. primary completion date June 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 10 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Sealant
Application of preventive agent
• Adhesive and Sealant
Application of preventive agent and technique for control moisture

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Campinas, Brazil Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Outcome
Type Measure Description Time frame Safety issue
Primary Sealant retention and prevention of dental caries assessed by defined clinical scoring system Clinical scoring system: adapted criteria proposed by Feigal et al. (2000) 6-mouth Yes
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