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

NCT ID: NCT06265116

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2027-01-30

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

Conditions

Dental Caries Class II; Marginal Integrity of Composite Restorations With Universal Adhesives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bis-GMA-containing, HEMA-containing, one-step universal adhesive.

Each patient will randomly receive one class II restoration with one of the tested restorative systems

Group Type: ACTIVE_COMPARATOR

One-step universal adhesive

Intervention Type: OTHER

Each patient will receive a class II restoration using the corresponding group adhesive

Bis-GMA-free, HEMA-containing, one-step universal adhesive

Each patient will randomly receive one class II restoration with one of the tested restorative systems

Group Type: ACTIVE_COMPARATOR

One-step universal adhesive

Intervention Type: OTHER

Each patient will receive a class II restoration using the corresponding group adhesive

Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive

Each patient will randomly receive one class II restoration with one of the tested restorative systems

Group Type: ACTIVE_COMPARATOR

One-step universal adhesive

Intervention Type: OTHER

Each patient will receive a class II restoration using the corresponding group adhesive

Bis-GMA- containing, HEMA-containing, amide-based one-step universal adhesive

Each patient will randomly receive one class II restoration with one of the tested restorative systems

Group Type: ACTIVE_COMPARATOR

One-step universal adhesive

Intervention Type: OTHER

Each patient will receive a class II restoration using the corresponding group adhesive

Interventions

One-step universal adhesive

Each patient will receive a class II restoration using the corresponding group adhesive

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Omar Abd El-fattah

Phd researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Omar Abd El-Fattah Abd El-Maksoud

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

A0801024 CD

Identifier Type: -

Identifier Source: org_study_id