Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

NCT ID: NCT00643461

Last Updated: 2024-10-02

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

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adhesive A

Adhesive A

Intervention Type DEVICE

Applied per manufacturer's instructions.

Adhesive B

Adhesive B

Intervention Type DEVICE

Applied per manufacturer's instructions.

Adhesive C

Adhesive C

Intervention Type DEVICE

Applied per manufacturer's instructions.

Interventions

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Adhesive A

Applied per manufacturer's instructions.

Intervention Type DEVICE

Adhesive B

Applied per manufacturer's instructions.

Intervention Type DEVICE

Adhesive C

Applied per manufacturer's instructions.

Intervention Type DEVICE

Other Intervention Names

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Adper Scotchbond SE (3M ESPE) Adper Easy Bond (3M ESPE) Single Bond Plus (3M ESPE)

Eligibility Criteria

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Inclusion Criteria

* Must be at least 19 years of age
* Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
* Must be willing to sign consent form
* Must be willing and able to return to UAB clinic for 4 study appointments
* Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria

* Current participation in other restorative product studies
* Severe salivary gland dysfunction
* Rampant caries (cavities)
* Chronic periodontitis (gum disease)
* Known allergies to the study materials
* Unacceptable level of oral hygiene
* Inability or unwillingness to attend study appointments
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John O Burgess, MS, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham (UAB) School of Dentistry

Locations

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University of Alabama at Birmingham (UAB) School of Dentistry

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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CR-07-009

Identifier Type: -

Identifier Source: org_study_id

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