36-Month Clinical Evaluation of a Universal Adhesive

May 2, 2019 updated by: Cansu Atalay, Hacettepe University

36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive

The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were included in this study. Three groups were formed according to adhesive strategies used (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was used for all restorations by a single operator. The restorations were evaluated by two calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test was used for intragroup comparison.

Study Type

Interventional

Enrollment (Actual)

35

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 Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

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

18 years to 81 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 18 years old
  • good oral hygiene
  • available for recall
  • at least 20 teeth under occlusion
  • the presence of at least three non-carious cervical lesions

Exclusion Criteria:

  • poor oral hygiene
  • bruxism habits
  • severe or chronic periodontitis
  • If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.

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
EXPERIMENTAL: Scotchbond universal adhesive (etch-and-rinse)
Acid etch (enamel&dentin)+adhesive agent Intervention: Device: Adhesive agent
Device: Scotchbond Universal Adhesive (3M ESPE)
Adhesive system
EXPERIMENTAL: Scotchbond universal adhesive (selective-etch)
Acid etch (only enamel)+adhesive agent Intervention: Device: Adhesive agent
Device: Scotchbond Universal Adhesive (3M ESPE)
Adhesive system
EXPERIMENTAL: Scotchbond universal adhesive (self-etch)
Adhesive agent Intervention: Device: Adhesive agent
Device: Scotchbond Universal Adhesive (3M ESPE)
Adhesive system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal adaptation
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
From baseline to 36 month
Marginal staining
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction
From baseline to 36 month
Retention
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material
From baseline to 36 month
Postoperative sensitivity
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity
From baseline to 36 month
Seconder caries
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present
From baseline to 36 month

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

September 2, 2015

Primary Completion (ACTUAL)

September 2, 2018

Study Completion (ACTUAL)

September 2, 2018

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (ACTUAL)

May 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-17088

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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