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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Adper Easy Bond Self-etch dental adhesive

Bonding composite to restore Class I or Class II cavities

Intervention Type DEVICE

Other Intervention Names

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self etch adhesive with enamel etch

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No