Back to resultsAdhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
Primary Purpose
Dental Leakage
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Self-etch adhesive (Kuraray, Tokyo, Japan)
Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Sponsored by
About this trial
This is an interventional treatment trial for Dental Leakage focused on measuring Resin Composite, Randomized Clinical Trial, Operative Dentistry
Eligibility Criteria
Inclusion Criteria:
- Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
- Patients with normal and full occlusion.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients must have a good oral hygiene.
- Patients with opposing teeth should be natural with no restorations.
Exclusion Criteria:
- High caries risk patients with extremely poor oral hygiene.
- Patients involved in orthodontic treatment or periodontal surgery.
- Patients with periodontally involved teeth (chronic periodontitis).
- Patients with heavy bruxism habits and clenching.
- Patients with abutments should be excluded.
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Fuji Bond LC (Glass ionomer based adhesive)
Riva Bond LC (Glass ionomer based adhesive)
Single Bond Universal (self-etch adhesive)
Clearfill S3 Bond (self-etch adhesive)
OptiBond FL (three step etch & rinse adhesive)
Arm Description
Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth
Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth
Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth
Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth
Patients received in Class V cavity preparation OptiBond FL (three step etch & rinse adhesive) on one tooth of the mouth
Outcomes
Primary Outcome Measures
Percentage % of patients with marginal staining
Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Secondary Outcome Measures
Full Information
NCT ID
NCT05161559
First Posted
December 3, 2021
Last Updated
December 15, 2021
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT05161559
Brief Title
Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
Official Title
Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura 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
This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.
Detailed Description
The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.
The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Leakage
Keywords
Resin Composite, Randomized Clinical Trial, Operative Dentistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fuji Bond LC (Glass ionomer based adhesive)
Arm Type
Experimental
Arm Description
Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth
Arm Title
Riva Bond LC (Glass ionomer based adhesive)
Arm Type
Experimental
Arm Description
Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth
Arm Title
Single Bond Universal (self-etch adhesive)
Arm Type
Experimental
Arm Description
Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth
Arm Title
Clearfill S3 Bond (self-etch adhesive)
Arm Type
Experimental
Arm Description
Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth
Arm Title
OptiBond FL (three step etch & rinse adhesive)
Arm Type
Experimental
Arm Description
Patients received in Class V cavity preparation OptiBond FL (three step etch & rinse adhesive) on one tooth of the mouth
Intervention Type
Procedure
Intervention Name(s)
Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Intervention Description
Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Intervention Type
Procedure
Intervention Name(s)
Self-etch adhesive (Kuraray, Tokyo, Japan)
Intervention Description
No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)
Intervention Type
Procedure
Intervention Name(s)
Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Intervention Description
Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)
Primary Outcome Measure Information:
Title
Percentage % of patients with marginal staining
Description
Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Time Frame
3 years after restoration procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
Patients with normal and full occlusion.
Patients with tooth gives positive response to testing with an electric pulp tester.
Patients must have a good oral hygiene.
Patients with opposing teeth should be natural with no restorations.
Exclusion Criteria:
High caries risk patients with extremely poor oral hygiene.
Patients involved in orthodontic treatment or periodontal surgery.
Patients with periodontally involved teeth (chronic periodontitis).
Patients with heavy bruxism habits and clenching.
Patients with abutments should be excluded.
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
study Protocol, Statistical Analysis Plan can be shared to other researchers
IPD Sharing Time Frame
Data will be available within 3 Months for 5 years
IPD Sharing Access Criteria
For anyone
Learn more about this trial
Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
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