One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations
Dental Caries Class II · Marginal Integrity of Composite Restorations With Universal Adhesives
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 20 years - 40 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 48 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
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
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
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
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
One-step universal adhesive OTHER
Each patient will receive a class II restoration using the corresponding group adhesive
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percentage of functional and biological properties for each group
Time frame: 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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Omar Abd El-Fattah Abd El-MaksoudAl Mansurah, Dakahlia Governorate, EgyptStatus unknown
Study team and timeline
- Lead sponsor
- Mansoura University
- Study start
- Jan 23, 2024 Actual
- Primary completion
- Jan 23, 2027 Estimated
- Study completion
- Jan 30, 2027 Estimated
- First posted
- Feb 20, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
One-Step Universal Adhesives: A 3-year Randomized Comparative Clinical Trial in Class II Composite Restorations
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026