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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02105896
Other study ID # 13-2235
Secondary ID
Status Completed
Phase N/A
First received March 27, 2014
Last updated June 18, 2015
Start date November 2013
Est. completion date October 2014

Study information

Verified date June 2015
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 82 Years
Eligibility 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:

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States The University of North Carolina School of Dentistry Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Dentsply International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline to 6-year follow-up in cavosurface margin discoloration. 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). No
Other Change from baseline to 6-year follow-up in secondary caries. 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). No
Other Change from baseline to 6-year follow-up in anatomic form. 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). No
Other Change from baseline to 6-year follow-up in marginal adaptation and/or integrity. 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). No
Other Change from baseline to 6-year follow-up in post-operative sensitivity. 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). No
Primary Change from baseline to 6-year follow-up in retention. 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). No
Secondary Change from baseline to 6-year follow-up in color match. 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). No
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