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

Solventum US LLC

Status: Completed

Conditions: Dental Caries

Treatments: Device: Adper Easy Bond Self-etch dental adhesive

Study type: Observational

Funder types: Industry

Identifiers

NCT01369134

CR-10-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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