NCT04708223

Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite

A 24-Month Clinical Evaluation of an Ultra-rapid Polymerizing Resin Composite

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.

Detailed description

Patients, requiring posterior tooth restorations Class I and II or requesting amalgam restoration replacement, were treated in the clinical investigation. Each patient received two composite restorations in the posterior region.

Conditions

• Caries
• Defective Tooth Restorations

Interventions

Type	Name	Description
DEVICE	Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)	Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
DEVICE	Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)	Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Timeline

• Start date: 2018-09-01
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2021-01-13
• Last updated: 2025-10-23
• Results posted: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study