NCT06369779

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

Clinical Evaluation of Class I and II Cavities Restored With the Combination of a New Flowable and a New Sculptable Universal Bulk-fill Composite: A Prospective Single Arm Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)

Interventions

Type	Name	Description
DEVICE	TM Fill in combination with TM Flow	The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).

Timeline

• Start date: 2024-05-13
• Primary completion: 2024-08-12
• Completion: 2030-12-01
• First posted: 2024-04-17
• Last updated: 2025-10-23
• Results posted: 2025-05-31

Locations

1 site across 1 country: Liechtenstein