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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Wear
• Intervention / Treatment: Device: Gluma Universal; Device: All Bond Universal; Drug: Single Bond2

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria will be as follows:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

7

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performances of different adhesives	Two year examinations according to USPHS criteria	Two years

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: January 28, 2018
• First Posted (ACTUAL): January 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear
• Other Study ID Numbers: Universal Clinical NCCLs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No