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

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT03415516

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Wear	Device: Gluma Universal Device: All Bond Universal Drug: Single Bond2	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gluma Universal, self-etch mode (GSE)	Device: Gluma Universal Adhesive systems
Experimental: Gluma Universal, selective etching (GSL)	Device: Gluma Universal Adhesive systems
Experimental: Gluma Universal, etch&rinse (GER)	Device: Gluma Universal Adhesive systems
Experimental: All Bond Universal, self-etch (ASE)	Device: All Bond Universal Adhesive systems
Experimental: All Bond Universal, selective etching (ASL)	Device: All Bond Universal Adhesive systems
Experimental: All Bond Universal, etch&rinse (AER)	Device: All Bond Universal Adhesive systems
Experimental: Single Bond2, etch&rinse (SBU)	Drug: Single Bond2 Adhesive systems

Outcome Measures

Primary Outcome Measures

Clinical performances of different adhesives [Two years]
Two year examinations according to USPHS criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion criteria will be as follows:

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

Exclusion Criteria:

Exlusion criteria will be:

poor gingival health,
uncontrolled, rampant caries,
bruxism,
removable partial dentures,
xerostomia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Fatma Dilşad Öz, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT03415516

Other Study ID Numbers:

Universal Clinical NCCLs

First Posted:

Jan 30, 2018

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth Wear

Study Results

No Results Posted as of Sep 14, 2021