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Recruiting
NCT05748327
Trial With Two New Tooth-colored Restorative Materials in Class /II Cavities
Conditions: Caries, Defective Restorations
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 58
Sponsor: Ivoclar Vivadent AG
Location: Belgium
Summary
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).
Eligibility Criteria
Inclusion Criteria:Subject's age between 18 and 65 years oldClass I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molarsVital teeth2 restorations per patient: both cavities should have comparable size and dimensionsPresence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)Low to moderate caries rate/normal periodontal status with good home careExclusion Criteria:Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)Pulp exposure or signs of pulpal infectionNo signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity)History of allergy to glass ionomer, acrylate/methacrylate monomersPregnancyChronic disease with oral manifestations or primary oral pathologyBad oral hygieneHigh caries rate or periodontal problemsAbsence of antagonistsAbsence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)
Source: ClinicalTrials.gov (NCT05748327). StuddyBuddy aggregates publicly available trial information.