Clinical trial NCT02105896: Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall
Official title: Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Bonding
Keywords: dental bonding
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Dentsply International
First posted: 2014-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to 6-year follow-up in retention.
timeFrame: sole visit (6 years post participation in related study).
Secondary outcomes:
measure: Change from baseline to 6-year follow-up in color match.
timeFrame: sole visit (6 years post participation in related study).
Other outcomes:
measure: Change from baseline to 6-year follow-up in cavosurface margin discoloration.
timeFrame: sole visit (6 years post participation in related study).
measure: Change from baseline to 6-year follow-up in secondary caries.
timeFrame: sole visit (6 years post participation in related study).
measure: Change from baseline to 6-year follow-up in anatomic form.
timeFrame: sole visit (6 years post participation in related study).
measure: Change from baseline to 6-year follow-up in marginal adaptation and/or integrity.
timeFrame: sole visit (6 years post participation in related study).
measure: Change from baseline to 6-year follow-up in post-operative sensitivity.
timeFrame: sole visit (6 years post participation in related study).
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina School of Dentistry
state: North Carolina
Study officials:
affiliation: The University of North Carolina School of Dentistry
name: Lee Boushell, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: