Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall

June 18, 2015 updated by: Lee Boushell, DMD, MS, University of North Carolina, Chapel Hill

Purpose: To evaluate the performance of several dental adhesives used for bonding tooth-colored fillings to teeth 6 years after the fillings have been placed.

Participants: Subjects which had participated in the study entitled "Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives" (IRB Study #07-0673).

Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a direct, visual examination. Close-up intra-oral clinical photographs of each filling will be made. An impression of the filling may be obtained.

The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673 is to evaluate the fillings placed according to the following characteristics: Retention; Color match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal adaptation and/or integrity; Post-operative sensitivity.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

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

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina School of Dentistry

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

25 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who participated in a 2007 study entitled "Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives" (UNC IRB Study #07-0673).

Description

Inclusion Criteria:

  • Subjects who participated in a 2007 study entitled "Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives" (UNC IRB Study #07-0673).

Exclusion Criteria:

  • none

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

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 6-year follow-up in retention.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 6-year follow-up in color match.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 6-year follow-up in cavosurface margin discoloration.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).
Change from baseline to 6-year follow-up in secondary caries.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).
Change from baseline to 6-year follow-up in anatomic form.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).
Change from baseline to 6-year follow-up in marginal adaptation and/or integrity.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).
Change from baseline to 6-year follow-up in post-operative sensitivity.
Time Frame: sole visit (6 years post participation in related study).
Each filling will be evaluated using the same modified United States Public Health Service (USPHS) direct evaluation procedures as were used during the 07-0673 study. Intraoral clinical photos will be obtained. Polyvinylsiloxane impressions of the filling and adjacent tooth structure may be obtained for those patients who had impressions made during the 07-0673 study.
sole visit (6 years post participation in related study).

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Dentsply International

Investigators

  • Principal Investigator: Lee Boushell, DMD, MS, The University of North Carolina School of Dentistry

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

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 18, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-2235

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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