One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations

Not Applicable

Active, not recruiting

• Conditions: Dental Caries Class II; Marginal Integrity of Composite Restorations With Universal Adhesives
• Interventions: Other: One-step universal adhesive

• Registration Number: NCT06265116
• Lead Sponsor: Mansoura University

Brief Summary

to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.

Detailed Description

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split-mouth design. A total of forty-eight adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation

Study Timeline

• Study Start: 2024-01-23
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2027-01-23
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5.
• The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance.
• Teeth to be restored must be in normal occlusion with the natural antagonist teeth.
• Vital teeth with no signs of pulpal inflammation or pathological lesions.
• Normal periodontal status and good oral hygiene.
• Good likelihood of recall availability.

Exclusion Criteria

• Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage.
• Partly erupted or endodontic treated teeth.
• Poor oral hygiene or severe periodontitis.
• Absence of neighboring or antagonist teeth.
• Patients with known allergy to any component of the study materials.
• Patients with unstable medical conditions.
• Patients with known unavailability to attend recall visits.
• Pregnant or lactating females.
• Patients with heavy para-functional habits, fractured, or visibly cracked teeth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bis-GMA-containing, HEMA-containing, one-step universal adhesive.	One-step universal adhesive	Each patient will randomly receive one class II restoration with one of the tested restorative systems
Bis-GMA-free, HEMA-containing, one-step universal adhesive	One-step universal adhesive	Each patient will randomly receive one class II restoration with one of the tested restorative systems
Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive	One-step universal adhesive	Each patient will randomly receive one class II restoration with one of the tested restorative systems
Bis-GMA- containing, HEMA-containing, amide-based one-step universal adhesive	One-step universal adhesive	Each patient will randomly receive one class II restoration with one of the tested restorative systems

Primary Outcome Measures

Name	Time	Method
Percentage of functional and biological properties for each group	3 years	Percentage of functional and biological properties that will be clinically assessed using recently revised World Dental Federation parameters for each restorative system group

Trial Locations

Locations (1)

Omar Abd El-Fattah Abd El-Maksoud; 🇪🇬 Mansoura, Dakahlia, Egypt