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

Not Applicable

Completed

• Conditions: Dental Leakage
• Interventions: 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)

• Registration Number: NCT05161559
• Lead Sponsor: Mansoura University

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?

Study Timeline

• Study Start: 2018-08-30
• Primary Completion: 2021-09-10
• Study Completion: 2021-10-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-15
• Last Update Submitted: 2021-12-15
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fuji Bond LC (Glass ionomer based adhesive)	Chemical bond adhesive (GC, Corporation, Tokyo, Japan)	Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth
Single Bond Universal (self-etch adhesive)	Self-etch adhesive (Kuraray, Tokyo, Japan)	Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth
Riva Bond LC (Glass ionomer based adhesive)	Chemical bond adhesive (GC, Corporation, Tokyo, Japan)	Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth
Clearfill S3 Bond (self-etch adhesive)	Self-etch adhesive (Kuraray, Tokyo, Japan)	Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth
OptiBond FL (three step etch & rinse adhesive)	Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)	Patients received in Class V cavity preparation OptiBond FL (three step etch \& rinse adhesive) on one tooth of the mouth

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt