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| Name | Class |
|---|---|
| Dentsply International | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Subjects who participated in a 2007 study entitled "Clinical Evaluation of New Total-Etch and Self-Etch Dental Adhesives" (UNC IRB Study #07-0673).
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| Name | Affiliation | Role |
|---|---|---|
| Lee Boushell, DMD, MS | The University of North Carolina School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
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| sole visit (6 years post participation in related study). |
| sole visit (6 years post participation in related study). |
| 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). |
| 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). |
| 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). |
| 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). |