Clinical Trial

Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment

Active, Not Recruiting
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Summary
The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-04-12; most recent amendment 2025-09-26.
Status change: Recruiting → Active, Not Recruiting 2025-01-10
Status change: Not Yet Recruiting → Recruiting 2024-05-24
Trial Details
NCT Number NCT06369779
Lead Sponsor Ivoclar Vivadent AG
Conditions Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
Enrollment 65 participants
Start Date 2024-05-13
Primary Completion 2024-08-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-23