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NCT05751382
Evaluation of Self-adhesive Hybrid Resin Composite Compared to a Traditional Composite Resin in Restorations of NCCLs
Conditions: Tooth Restoration
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 50
Sponsor: Dentsply Sirona Implants and Consumables
Location: Italy
Summary
This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs).
The study consists of a 3-year long follow-up period.
Eligibility Criteria
Inclusion Criteria:Patients aging from 18 to 7040-60% women, 40-60% menPatients who present at least 2 cervical lesions on canines and / or upper premolars on vital teethPatients who are not allergic or sensitive to the ingredients contained in the productsThe test patient consents to the restorative treatment in line with the study´s criteria (informed consent)Sufficiently understanding of the languageExclusion Criteria:Extremely low level of oral hygieneTeeth with previous restorationsNot possible adequate isolation of the operating areaPatients with serious systemic diseasesDevitalized teeth or with pulpitis in progressPeriodontal problems on the elements to be restored
Source: ClinicalTrials.gov (NCT05751382). StuddyBuddy aggregates publicly available trial information.