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

Dental Caries Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265116
• Other study ID #: A0801024 CD
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: January 30, 2027

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: Omar A Abd El-Maksoud
• Phone: 01024366555
• Email: omarabdelfata7.92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 30, 2027
• Est. primary completion date: January 23, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II

Intervention

Other:
• One-step universal adhesive
Each patient will receive a class II restoration using the corresponding group adhesive

Locations

Country	Name	City	State
Egypt	Omar Abd El-Fattah Abd El-Maksoud	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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