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

NCT02105896 | Completed

• 1 other identifier: 13-2235
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Bonding

Keywords

dental bonding

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Change from baseline to 6-year follow-up in color match.

  sole visit (6 years post participation in related study).

Other Outcomes (5)

• Change from baseline to 6-year follow-up in cavosurface margin discoloration.

  sole visit (6 years post participation in related study).

• Change from baseline to 6-year follow-up in secondary caries.

  sole visit (6 years post participation in related study).

• Change from baseline to 6-year follow-up in anatomic form.

  sole visit (6 years post participation in related study).

Eligibility Criteria

• Age: 25 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Dentsply International: collaborator

Study Sites (1)

The University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Lee Boushell, DMD, MS

  The University of North Carolina School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Operative Dentistry

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 7, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

US (1)