Randomized Clinical Trial of Occlusal Sealant

Study Overview
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Sealant
* Device: Adhesive and Sealant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, pit and fissure sealants, tooth eruption, retention, adhesive system, intermediary layer