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

Dental Leakage Clinical Trial

Official title:

Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161559
• Other study ID #: A12151221
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Leakage

Intervention

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)
• Self-etch adhesive (Kuraray, Tokyo, Japan)
No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)
• Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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