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NCT00643461 Clinical Trial

Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Dental Caries Clinical Trial

Official title:
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643461
Other study ID # CR-07-009
Secondary ID
Status Completed
Phase N/A
First received March 20, 2008
Last updated April 16, 2013
Start date April 2008
Est. completion date June 2012

Study information
Verified date April 2013
Source 3M
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date June 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Adhesive A
Applied per manufacturer's instructions.
• Adhesive B
Applied per manufacturer's instructions.
• Adhesive C
Applied per manufacturer's instructions.

Locations
Country Name City State
United States University of Alabama at Birmingham (UAB) School of Dentistry Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retention of the restoration. 6, 12, 24, 36 months post-placement No
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