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NCT07731061
Clinical Performance of Two HEMA-Free Universal Adhesive Systems
Conditions: Cervical Caries
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Cairo University
Summary
This randomized controlled clinical trial aims to compare the 12-month clinical performance of two HEMA-free universal adhesive systems for restoring anterior cervical carious lesions. Participants will be randomly allocated (1:1) to receive restorations using either a two-bottle HEMA-free universal adhesive (G2-Bond Universal) or a one-bottle HEMA-free universal adhesive (BeautiBond Xtreme), both applied in self-etch mode. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, and postoperative sensitivity, evaluated at baseline (24 hours), 6 months, and 12 months using the modified USPHS criteria.
Eligibility Criteria
Inclusion Criteria:
. Patients aged from 18 to 55 years.
* Patients with cervical carious lesions on the labial surfaces of anterior teeth.
* Lesions classified as ICDAS 3 and 4.
* Patients with good general health.
* Patients able and willing to attend the follow-up visits at baseline, 6 months and 12 months.
Exclusion Criteria:
* Patients with severe or chronic periodontal disease.
* Patients with poor oral hygiene or uncontrolled plaque accumulation.
* Patients with bruxism or other parafunctional habits that may affect restoration survival.
* Non-vital teeth.
* Fractured or cracked teeth.
* Teeth with defective existing cervical restorations.
* Root caries extending beyond the restorative indication of the study.
* Pregnant or lactating patients.
* Patients with known allergy or hypersensitivity to any component of the adhesive systems or restorative material used in the study.
* Patients unable to attend the scheduled follow-up visits.
Source: ClinicalTrials.gov (NCT07731061). StuddyBuddy aggregates publicly available trial information.