Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

March 12, 2021 updated by: Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Time Frame: 24 months
Long-term clinical success of different universal adhesives under fissure sealants
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Zafer C Cehreli, Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 31, 2022

Primary Completion (ANTICIPATED)

March 30, 2024

Study Completion (ANTICIPATED)

March 30, 2025

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (ESTIMATE)

September 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUDHF-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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