NCT01925040

Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study

Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Heraeus Kulzer GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the clinical performance of a new resin based filling material to an established resin-based filling material in posterior teeth at 2 different study centers.

Detailed description

The objective of this study is to compare the performance of the composite resin Venus Pearl and a commercially available control composite material for the restoration of class II-cavities. Primary endpoints of the study are a mean score for each patient calculated from aesthetic, functional attribute and biological parameters. Secondary endpoints are the evaluation of secondary caries, plaque accumulation and gingival reactions and the comparison of the primary score at week 1, month 6, month 12 and month 24 after restoration. Beside this, the single components of the three categories of the primary endpoints will be compared. The study will be executed as a multi-center (Oregon Health \& Science University, Portland, OR, USA and Medical School Hannover, Hannover, Germany), single-blinded and randomized clinical investigation. 90 comparable cavities per study site will be treated (45 cavities for each material at each site).

Conditions

• Caries
• Unsatisfactory or Defective Restoration of Tooth

Interventions

Type	Name	Description
DEVICE	Placement of restoration	Placement of restorations

Timeline

• Start date: 2013-06-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2013-08-19
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

2 sites across 2 countries: United States, Germany