Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs

NCT ID: NCT03415516

Last Updated: 2021-09-14

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

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2018-11-01

Brief Summary

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The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch\&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch\&rinse, SB (Control): Single Bond2+etch\&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.

Detailed Description

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Conditions

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Tooth Wear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Gluma Universal, self-etch mode (GSE)

Group Type EXPERIMENTAL

Gluma Universal

Intervention Type DEVICE

Adhesive systems

Gluma Universal, selective etching (GSL)

Group Type EXPERIMENTAL

Gluma Universal

Intervention Type DEVICE

Adhesive systems

Gluma Universal, etch&rinse (GER)

Group Type EXPERIMENTAL

Gluma Universal

Intervention Type DEVICE

Adhesive systems

All Bond Universal, self-etch (ASE)

Group Type EXPERIMENTAL

All Bond Universal

Intervention Type DEVICE

Adhesive systems

All Bond Universal, selective etching (ASL)

Group Type EXPERIMENTAL

All Bond Universal

Intervention Type DEVICE

Adhesive systems

All Bond Universal, etch&rinse (AER)

Group Type EXPERIMENTAL

All Bond Universal

Intervention Type DEVICE

Adhesive systems

Single Bond2, etch&rinse (SBU)

Group Type EXPERIMENTAL

Single Bond2

Intervention Type DRUG

Adhesive systems

Interventions

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Gluma Universal

Adhesive systems

Intervention Type DEVICE

All Bond Universal

Adhesive systems

Intervention Type DEVICE

Single Bond2

Adhesive systems

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. being 18 years or older,
2. having no medical or behavioral problems preventing then from attending review visits,
3. having at least 7 tooth with NCCLs (d) having antagonist teeth.

Exclusion Criteria

Exlusion criteria will be:

1. poor gingival health,
2. uncontrolled, rampant caries,
3. bruxism,
4. removable partial dentures,
5. xerostomia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fatma Dilşad Öz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Universal Clinical NCCLs

Identifier Type: -

Identifier Source: org_study_id

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