Randomized Clinical Trial of Occlusal Sealant

NCT ID: NCT02589743

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Fluroshield - F (Sealant)

Pit and fissure sealing using only sealant

Group Type ACTIVE_COMPARATOR

Sealant

Intervention Type DEVICE

Application of preventive agent

Single Bond and F (Adhesive and Sealant)

Pit and fissure sealing using adhesive and sealant

Group Type EXPERIMENTAL

Adhesive and Sealant

Intervention Type DEVICE

Application of preventive agent and technique for control moisture

Helioseal Clear Chroma - H (Sealant)

Pit and fissure sealing using only sealant

Group Type ACTIVE_COMPARATOR

Sealant

Intervention Type DEVICE

Application of preventive agent

Excite and H (Adhesive and Sealant)

Pit and fissure sealing using adhesive and sealant

Group Type EXPERIMENTAL

Adhesive and Sealant

Intervention Type DEVICE

Application of preventive agent and technique for control moisture

Interventions

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Sealant

Application of preventive agent

Intervention Type DEVICE

Adhesive and Sealant

Application of preventive agent and technique for control moisture

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Profa. Dra. Regina Maria Puppin Rontani

Teacher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamila Kantovitz, Phd

Role: PRINCIPAL_INVESTIGATOR

Piracicaba Dental Scholl - University of Campinas

Kelly Moreira, DDS

Role: PRINCIPAL_INVESTIGATOR

Piracicaba Dental Scholl - University of Campinas

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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