NCT00643461CompletedNot Applicable
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Solventum US LLC
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Retention of the restoration.
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Retention of the restoration.
Time Frame: 6, 12, 24, 36 months post-placement
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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