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

Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Adper Easy Bond Self-etch dental adhesive

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Dental patients

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of the Restoration	Bonded filling still in place	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of the study restoration	Restoration in satisfactory clinical function at one year	one year

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Carlos Munoz, DDS, Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimated): June 8, 2011

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Adult; self-etch adhesive; selective enamel etching; Adper Easy Bond; Supreme Ultra; Molar and premolar teeth; Class I and II cavities
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CR-10-014