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

Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems

This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.

Study Overview

• Status: Completed
• Conditions: Dental Leakage
• Intervention / Treatment: Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan); Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan); Procedure: Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years after restoration procedure

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Resin Composite; Operative Dentistry
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Leakage
• Other Study ID Numbers: A12151221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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