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

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ClinicalTrials.gov Identifier: NCT02105896
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : June 19, 2015
Sponsor:
Collaborator:
Dentsply International
Information provided by (Responsible Party):
Lee Boushell, DMD, MS, University of North Carolina, Chapel Hill

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.


Condition or disease
Dental Bonding

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Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014



Primary Outcome Measures :
  1. Change from baseline to 6-year follow-up in retention. [ Time Frame: 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 Outcome Measures :
  1. Change from baseline to 6-year follow-up in color match. [ Time Frame: 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 Outcome Measures:
  1. Change from baseline to 6-year follow-up in cavosurface margin discoloration. [ Time Frame: 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.

  2. Change from baseline to 6-year follow-up in secondary caries. [ Time Frame: 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.

  3. Change from baseline to 6-year follow-up in anatomic form. [ Time Frame: 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.

  4. Change from baseline to 6-year follow-up in marginal adaptation and/or integrity. [ Time Frame: 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.

  5. Change from baseline to 6-year follow-up in post-operative sensitivity. [ Time Frame: 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.



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Ages Eligible for Study:   25 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105896


Locations
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United States, North Carolina
The University of North Carolina School of Dentistry
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Dentsply International
Investigators
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Principal Investigator: Lee Boushell, DMD, MS The University of North Carolina School of Dentistry

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Responsible Party: Lee Boushell, DMD, MS, Associate Professor, Operative Dentistry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02105896     History of Changes
Other Study ID Numbers: 13-2235
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015
Keywords provided by Lee Boushell, DMD, MS, University of North Carolina, Chapel Hill:
dental bonding