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

NCT05161559 | Completed

• 1 other identifier: A12151221
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Leakage

Keywords

Resin Composite; Randomized Clinical Trial; Operative Dentistry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Fuji Bond LC (Glass ionomer based adhesive)

EXPERIMENTAL

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)

Riva Bond LC (Glass ionomer based adhesive)

EXPERIMENTAL

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)

Single Bond Universal (self-etch adhesive)

EXPERIMENTAL

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)

Clearfill S3 Bond (self-etch adhesive)

EXPERIMENTAL

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)

OptiBond FL (three step etch & rinse adhesive)

EXPERIMENTAL

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)

Interventions

Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA) PROCEDURE

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

OptiBond FL (three step etch & rinse adhesive)

Self-etch adhesive (Kuraray, Tokyo, Japan) PROCEDURE

No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)

Clearfill S3 Bond (self-etch adhesive); Single Bond Universal (self-etch adhesive)

Chemical bond adhesive (GC, Corporation, Tokyo, Japan) PROCEDURE

Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Fuji Bond LC (Glass ionomer based adhesive); Riva Bond LC (Glass ionomer based adhesive)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Conditions

Dental Leakage

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: August 30, 2018
• Primary Completion: September 10, 2021
• Study Completion: October 30, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 3 Months for 5 years
• Access Criteria: For anyone

Locations

EG (1)