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

NCT06265116 | Active Not Recruiting

• 1 other identifier: A0801024 CD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

ACTIVE COMPARATOR

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

Other: One-step universal adhesive

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

ACTIVE COMPARATOR

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

Other: One-step universal adhesive

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

ACTIVE COMPARATOR

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

Other: One-step universal adhesive

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

ACTIVE COMPARATOR

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

Other: One-step universal adhesive

Interventions

One-step universal adhesive 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; Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive; Bis-GMA-containing, HEMA-containing, one-step universal adhesive.; Bis-GMA-free, HEMA-containing, one-step universal adhesive

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Omar Abd El-Fattah Abd El-Maksoud

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd researcher

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 20, 2024
• Study Start: January 23, 2024
• Primary Completion (Estimated): January 23, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)