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Active Not Recruiting
NCT05748327
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Conditions: Caries, Defective Restorations
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 58
Sponsor: Ivoclar Vivadent AG
Location: KU Leuven Leuven
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 old
* Class 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/molars
* Vital teeth
* 2 restorations per patient: both cavities should have comparable size and dimensions
* Presence 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 care
Exclusion Criteria:
* Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
* Pulp exposure or signs of pulpal infection
* No signs of pulpitis or hypersensitivity (Visual analog scale \< 3 on biting and temperature sensitivity)
* History of allergy to glass ionomer, acrylate/methacrylate monomers
* Pregnancy
* Chronic disease with oral manifestations or primary oral pathology
* Bad oral hygiene
* High caries rate or periodontal problems
* Absence of antagonists
* Absence 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.