Randomized Clinical Trial of Occlusal Sealant

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT02589743

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Sealant Device: Adhesive and Sealant	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fluroshield - F (Sealant) Pit and fissure sealing using only sealant	Device: Sealant Application of preventive agent
Experimental: Single Bond and F (Adhesive and Sealant) Pit and fissure sealing using adhesive and sealant	Device: Adhesive and Sealant Application of preventive agent and technique for control moisture
Active Comparator: Helioseal Clear Chroma - H (Sealant) Pit and fissure sealing using only sealant	Device: Sealant Application of preventive agent
Experimental: Excite and H (Adhesive and Sealant) Pit and fissure sealing using adhesive and sealant	Device: Adhesive and Sealant Application of preventive agent and technique for control moisture

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Campinas, Brazil
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

Principal Investigator: Kamila Kantovitz, Phd, Piracicaba Dental Scholl - University of Campinas
Principal Investigator: Kelly Moreira, DDS, Piracicaba Dental Scholl - University of Campinas