Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions
Primary Purpose
Tooth Diseases
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clearfil Univesal Bond
IBond Universal
G-Premio Bond
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases focused on measuring non-caries cervical lesion, universal adhesives
Eligibility Criteria
Inclusion Criteria:
- 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.
Exclusion Criteria:
- Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group CU (Clearfil Universal)
Group IU (Ibond Universal)
Group GP (G-Premio)
Arm Description
Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system
IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system
G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system
Outcomes
Primary Outcome Measures
Clinical performances of different universal adhesives
Two year results according to USPHS criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT03415412
First Posted
December 23, 2017
Last Updated
August 21, 2023
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT03415412
Brief Title
Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions
Official Title
Clinical Evaluation of Three Different Universal Adhesives and a Universal Flowable Composite for Restoration of Non-carious Cervical Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation.
The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA).
Patients will be recalled at baseline and will be recalled at control periods after placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
non-caries cervical lesion, universal adhesives
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group CU (Clearfil Universal)
Arm Type
Experimental
Arm Description
Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system
Arm Title
Group IU (Ibond Universal)
Arm Type
Experimental
Arm Description
IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system
Arm Title
Group GP (G-Premio)
Arm Type
Experimental
Arm Description
G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system
Intervention Type
Device
Intervention Name(s)
Clearfil Univesal Bond
Intervention Description
Adhesive systems
Intervention Type
Device
Intervention Name(s)
IBond Universal
Intervention Description
Adhesive systems
Intervention Type
Device
Intervention Name(s)
G-Premio Bond
Intervention Description
Adhesive systems
Primary Outcome Measure Information:
Title
Clinical performances of different universal adhesives
Description
Two year results according to USPHS criteria
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.
Exclusion Criteria:
Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.
12. IPD Sharing Statement
Citations:
PubMed Identifier
35477817
Citation
Oz FD, Ozturk C, Soleimani R, Gurgan S. Sixty-month follow up of three different universal adhesives used with a highly-filled flowable resin composite in the restoration of non-carious cervical lesion. Clin Oral Investig. 2022 Aug;26(8):5377-5387. doi: 10.1007/s00784-022-04505-x. Epub 2022 Apr 27.
Results Reference
derived
Learn more about this trial
Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions
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