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Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05161559
Collaborator
(none)
60
Enrollment
1
Location
5
Arms
38
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
  • Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)
  • Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
 N/A

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?

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems
Actual Study Start Date :
Aug 30, 2018
Actual Primary Completion Date :
Sep 10, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fuji Bond LC (Glass ionomer based adhesive)

Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth

Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)
Experimental: Riva Bond LC (Glass ionomer based adhesive)

Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth

Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)
Experimental: Single Bond Universal (self-etch adhesive)

Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth

Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)
No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)
Experimental: Clearfill S3 Bond (self-etch adhesive)

Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth

Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)
No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)
Experimental: OptiBond FL (three step etch & rinse adhesive)

Patients received in Class V cavity preparation OptiBond FL (three step etch & rinse adhesive) on one tooth of the mouth

Procedure: Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Outcome Measures

Primary Outcome Measures

  1. Percentage % of patients with marginal staining [3 years after restoration procedure]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Patients with primary caries involving cervical surface only with ICDAS 2 and 3.

  2. Patients with normal and full occlusion.

  3. Patients with tooth gives positive response to testing with an electric pulp tester.

  4. Patients must have a good oral hygiene.

  5. Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

  1. High caries risk patients with extremely poor oral hygiene.

  2. Patients involved in orthodontic treatment or periodontal surgery.

  3. Patients with periodontally involved teeth (chronic periodontitis).

  4. Patients with heavy bruxism habits and clenching.

  5. Patients with abutments should be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Mansoura Egypt 35511

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05161559
Other Study ID Numbers:
  • A12151221
First Posted:
Dec 17, 2021
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mansoura University
Resin Composite
Randomized Clinical Trial
Operative Dentistry
Additional relevant MeSH terms:
Dental Leakage

Study Results

No Results Posted as of Dec 17, 2021