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Randomized Clinical Trial of Occlusal Sealant

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Sealant

Adhesive and Sealant

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring clinical trial, pit and fissure sealants, tooth eruption, retention, adhesive system, intermediary layer

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Fluroshield - F (Sealant)

Single Bond and F (Adhesive and Sealant)

Helioseal Clear Chroma - H (Sealant)

Excite and H (Adhesive and Sealant)

Arm Description

Pit and fissure sealing using only sealant

Pit and fissure sealing using adhesive and sealant

Pit and fissure sealing using only sealant

Pit and fissure sealing using adhesive and sealant

Outcomes

Primary Outcome Measures

Sealant retention and prevention of dental caries assessed by defined clinical scoring system

Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)

Secondary Outcome Measures

Full Information

NCT ID

NCT02589743

First Posted

October 17, 2015

Last Updated

October 27, 2015

Sponsor

University of Campinas, Brazil

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

1. Study Identification

Unique Protocol Identification Number

NCT02589743

Brief Title

Randomized Clinical Trial of Occlusal Sealant

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

clinical trial, pit and fissure sealants, tooth eruption, retention, adhesive system, intermediary layer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluroshield - F (Sealant)

Arm Type

Active Comparator

Arm Description

Pit and fissure sealing using only sealant

Arm Title

Single Bond and F (Adhesive and Sealant)

Arm Type

Experimental

Arm Description

Pit and fissure sealing using adhesive and sealant

Arm Title

Helioseal Clear Chroma - H (Sealant)

Arm Type

Active Comparator

Arm Description

Pit and fissure sealing using only sealant

Arm Title

Excite and H (Adhesive and Sealant)

Arm Type

Experimental

Arm Description

Pit and fissure sealing using adhesive and sealant

Intervention Type

Device

Intervention Name(s)

Sealant

Intervention Description

Application of preventive agent

Intervention Type

Device

Intervention Name(s)

Adhesive and Sealant

Intervention Description

Application of preventive agent and technique for control moisture

Primary Outcome Measure Information:

Title

Sealant retention and prevention of dental caries assessed by defined clinical scoring system

Description

Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)

Time Frame

6-mouth

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamila Kantovitz, Phd

Organizational Affiliation

Piracicaba Dental Scholl - University of Campinas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kelly Moreira, DDS

Organizational Affiliation

Piracicaba Dental Scholl - University of Campinas

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Randomized Clinical Trial of Occlusal Sealant

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