Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique

Completed

• Conditions: Dental Caries

• Registration Number: NCT01369134
• Lead Sponsor: Solventum US LLC

Brief Summary

Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

Detailed Description

There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years or older
• written informed consent
• regular dental attender, can return to clinic for study recalls
• good medical health
• normal saliva flow
• has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
• study teeth that are vital

Exclusion Criteria

• currently in an evaluation of other dental materials
• an irregular dental attender
• has unacceptable oral hygiene standards
• has chronic periodontitis or rampant caries
• has teeth with signs of periapical pathology
• has history of pulp problems, and/or needs pulp treatment
• women who are pregnant or breast-feeding
• has known allergy to resin composite or latex
• has serious chronic disease requiring hospitalization
• has oral soft tissue pathologies
• takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
• has current or recent history of alcohol or other substance abuse
• is an employee of the sponsor or the study site, or members of their immediate family
• has had any restorative treatment of teeth involved in the study in the last twelve months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention of the Restoration	one year	Bonded filling still in place

Secondary Outcome Measures

Name	Time	Method
Clinical performance of the study restoration	one year	Restoration in satisfactory clinical function at one year

Trial Locations

Locations (1)

School of Dental Medicine; 🇺🇸 Buffalo, New York, United States