Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

Not Applicable

Not yet recruiting

• Conditions: Dental Caries on Pit and Fissure Surface
• Interventions: Device: Adhesive agent

• Registration Number: NCT02897089
• Lead Sponsor: Hacettepe University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-15
• Study Start: 2022-03-31
• Primary Completion: 2024-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
All Bond universal adhesive	Adhesive agent	Acid etch+ All Bond universal adhesive agent+fissure sealant
All Bond universal	Adhesive agent	All Bond universal adhesive agent+fissure sealant
Scotchbond universal adhesive	Adhesive agent	Acid etch+ Scotchbond universal adhesive agent+fissure sealant
Clearfil universal adhesive	Adhesive agent	Acid etch+ Clearfil universal adhesive agent+fissure sealant
Total-etch Dental Adhesive	Adhesive agent	Acid etch+ Single Bond adhesive agent+fissure sealant
Scotchbond universal	Adhesive agent	Scotchbond universal adhesive agent+fissure sealant
Clearfil universal	Adhesive agent	Clearfil universal adhesive agent+fissure sealant

Primary Outcome Measures

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