Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

Sponsor

Hacettepe University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02897089

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries on Pit and Fissure Surface	Device: Adhesive agent	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2022

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hacettepe University

Investigators

Principal Investigator: Zafer C Cehreli, Prof, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Zafer Cavit Cehreli, DDS, PhD, Prof., Hacettepe University

ClinicalTrials.gov Identifier:

NCT02897089

Other Study ID Numbers:

HUDHF-1

First Posted:

Sep 13, 2016

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Prof., Hacettepe University

universal adhesive

fissure sealants

retention

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Mar 15, 2021