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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369134
• Other study ID #: CR-10-014
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: May 29, 2014
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Adper Easy Bond Self-etch dental adhesive
Bonding composite to restore Class I or Class II cavities

Locations

Country	Name	City	State
United States	School of Dental Medicine	Buffalo	New York

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	Bonded filling still in place	one year	No
Secondary	Clinical performance of the study restoration	Restoration in satisfactory clinical function at one year	one year	No