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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries Class II; Marginal Integrity of Composite Restorations With Universal Adhesives
• Intervention / Treatment: Other: One-step universal adhesive

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Omar Abd El-Fattah Abd El-Maksoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: One-step universal adhesive; Each patient will receive a class II restoration using the corresponding group adhesive
Active Comparator: 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	Other: One-step universal adhesive; Each patient will receive a class II restoration using the corresponding group adhesive
Active Comparator: 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	Other: One-step universal adhesive; Each patient will receive a class II restoration using the corresponding group adhesive
Active Comparator: 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	Other: One-step universal adhesive; Each patient will receive a class II restoration using the corresponding group adhesive

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): January 23, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: A0801024 CD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No