Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
September 30, 2024 updated by: Solventum US LLC
The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham (UAB) School of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Class V cavities
Description
Inclusion Criteria:
- Must be at least 19 years of age
- Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
- Must be willing to sign consent form
- Must be willing and able to return to UAB clinic for 4 study appointments
- Must be in good medical health and able to tolerate dental procedures
Exclusion Criteria:
- Current participation in other restorative product studies
- Severe salivary gland dysfunction
- Rampant caries (cavities)
- Chronic periodontitis (gum disease)
- Known allergies to the study materials
- Unacceptable level of oral hygiene
- Inability or unwillingness to attend study appointments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adhesive A
|
Applied per manufacturer's instructions.
Other Names:
|
|
Adhesive B
|
Applied per manufacturer's instructions.
Other Names:
|
|
Adhesive C
|
Applied per manufacturer's instructions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Retention of the restoration.
Time Frame: 6, 12, 24, 36 months post-placement
|
6, 12, 24, 36 months post-placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John O Burgess, MS, DDS, University of Alabama at Birmingham (UAB) School of Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
March 20, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (Estimated)
March 26, 2008
Study Record Updates
Last Update Posted (Actual)
October 2, 2024
Last Update Submitted That Met QC Criteria
September 30, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-07-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.