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Active Not RecruitingNCT07459374

Evaluating Universal Adhesives in Cervical Lesions

Evaluation of the Clinical Performance of Universal Adhesives in Non-Carious Cervical Lesions: A Randomized Controlled Clinical Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The aim of this randomized controlled clinical trial is to evaluate the 12-month clinical performance of restorations placed in NCCLs using universal adhesives with different compositions according to FDI criteria.

Detailed description

This controlled, randomized, single-blind clinical trial will compare the clinical effectiveness of three universal adhesive systems with different compositions in the restoration of non-carious cervical lesions. A total of 30 healthy volunteers aged 18-55 years will be included. Each participant must present with at least three vital posterior teeth with non-carious cervical lesions (≥3 lesions), with both enamel and dentin involvement and with antagonist teeth in occlusion. Each participant will receive restorations using all three adhesive systems in different teeth (split- mouth design). Randomization will be performed using a computer-generated randomization table (Research Randomizer Program). An experienced operator from the Department of Restorative Dentistry will perform all restorative procedures (AUT). Radiographs will be taken at baseline (before treatment) and at 12-, 24- and 36-month follow-up appointments to assess adaptation, marginal integrity, and proximity to the pulp. Additional radiographs will only be taken if clinically indicated (e.g., suspected endodontic involvement). Restorations will be evaluated immediately after placement, at 12-, 24- and 36-month using FDI evaluation criteria.

Conditions

Interventions

TypeNameDescription
DEVICEG2 Bond Universal, GC Europe N.V., Leuven, BelgiumG2 Bond Universal, GC Europe N.V., Leuven, Belgium
DEVICEScotchbond Universal Plus, 3M ESPE, St. Paul, MN, USAScotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA
DEVICETokuyama Universal Bond II, Tokuyama Dental, Tokyo, JapanTokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan

Timeline

Start date
2024-03-19
Primary completion
2025-03-19
Completion
2028-03-19
First posted
2026-03-09
Last updated
2026-03-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07459374. Inclusion in this directory is not an endorsement.