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Clinical Trials/NCT00643461
NCT00643461CompletedNot Applicable

Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Solventum US LLC1 site in 1 country46 target enrollmentStarted: April 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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