Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.

Detailed Description
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Sealants will placed on previously unsealed, caries-free permanent first molars, employing a split-mouth design. 100 patients will be included the study. The teeth will be randomized into eight groups according to the adhesive systems and modes placed under the tested resin-based sealant. Group1: Acid-Etch + Fissure sealant (ClinPro 3M ESPE, U.S.) (Control arm) Group2: All Bond Universal (Bisco Inc., Schaumburg,IL, U.S.) - with self etch technique + Fissure sealant ; Group3: All Bond Universal - total etch technique + Fissure sealant Group4: Scotchbond (Single Bond) Universal (3M ESPE, U.S.) - self etch technique + Fissure sealant Group5: Scotchbond (Single Bond) Universal - total etch technique + Fissure sealant Group6: Clearfil Universal Bond (Kuraray, Tokyo, Japan) - self etch technique + Fissure sealant Group7: Clearfil Universal Bond- total etch technique + Fissure sealant Group8: Single Bond Plus (3M ESPE)- total etch technique + Fissure sealant Clinical assessments will be performed according to modified USPHS criteria at 3, 6, 12, 18 and 24 months. Retention, seconder caries, marginal adaptation and marginal discoloration of the sealants will be evaluated. The data will be analyzed statistically using Fisher's Exact test and Kaplan-Meier analysis.

Official Title
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Clinical Performance of Fissure Sealants Bonded With Total and Self-etch Modes of Universal Adhesive Agents

Conditions
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Dental Caries on Pit and Fissure Surface

Intervention / Treatment
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* Device: Adhesive agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teeth having clinical indication of sealing with pit and fissure sealant. Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures. Exclusion Criteria: Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces. Patients with systemic diseases.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: acid-etch<br>Acid etch+fissure sealant | |
| Other: All Bond universal adhesive<br>Acid etch+ All Bond universal adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|
| Other: All Bond universal<br>All Bond universal adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|
| Other: Scotchbond universal adhesive<br>Acid etch+ Scotchbond universal adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|
| Other: Scotchbond universal<br>Scotchbond universal adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|
| Other: Clearfil universal adhesive<br>Acid etch+ Clearfil universal adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|
| Other: Clearfil universal<br>Clearfil universal adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|
| Other: Total-etch Dental Adhesive<br>Acid etch+ Single Bond adhesive agent+fissure sealant | Device: Adhesive agent<br>* Agents used to bond the restorative materials to teeth structure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria | Long-term clinical success of different universal adhesives under fissure sealants | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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universal adhesive, fissure sealants, retention