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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02105896

Enrollment

Registered

2014-04-07

Start date

2013-11-30

Completion date

2014-10-31

Last updated

2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Bonding

Keywords

dental bonding

Brief 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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to 82 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline to 6-year follow-up in retention.	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.

Secondary

Measure	Time frame	Description
Change from baseline to 6-year follow-up in color match.	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.

Other

Measure	Time frame	Description
Change from baseline to 6-year follow-up in secondary caries.	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.
Change from baseline to 6-year follow-up in marginal adaptation and/or integrity.	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.
Change from baseline to 6-year follow-up in post-operative sensitivity.	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.
Change from baseline to 6-year follow-up in anatomic form.	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.
Change from baseline to 6-year follow-up in cavosurface margin discoloration.	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.

Countries

United States

Outcome results