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

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ClinicalTrials.gov Identifier: NCT03415516
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Fatma Dilşad Öz, Hacettepe University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 1, 2015
Actual Primary Completion Date : November 1, 2015
Actual Study Completion Date : November 1, 2018
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Clinical performances of different adhesives [ Time Frame: Two years ]
    Two year examinations according to USPHS criteria


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Dr. Fatma Dilşad Öz, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03415516    
Other Study ID Numbers: Universal Clinical NCCLs
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Wear
Tooth Diseases
Stomatognathic Diseases