Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Completed

• Conditions: Dental Caries
• Interventions: Device: Adhesive C; Device: Adhesive A; Device: Adhesive B

• Registration Number: NCT00643461
• Lead Sponsor: Solventum US LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Study Start: 2008-04
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adhesive C	Adhesive C	-
Adhesive A	Adhesive A	-
Adhesive B	Adhesive B	-

Primary Outcome Measures

Name	Time	Method
Retention of the restoration.	6, 12, 24, 36 months post-placement

Trial Locations

Locations (1)

University of Alabama at Birmingham (UAB) School of Dentistry; 🇺🇸 Birmingham, Alabama, United States