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

NCT ID: NCT02105896

Last Updated: 2015-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Bonding

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dentsply International

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Lee Boushell, DMD, MS

Associate Professor, Operative Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lee Boushell, DMD, MS

Role: PRINCIPAL_INVESTIGATOR

The University of North Carolina School of Dentistry

Locations

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The University of North Carolina School of Dentistry

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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13-2235

Identifier Type: -

Identifier Source: org_study_id

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