NCT03198520

REFRAME RPD Post-Market Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Solvay Dental 360 · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the change in patient Oral Health-related Quality of Life (OHRQoL) from wearing a cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360TM polymer Removable Partial Denture (RPD) for 8 weeks.

Detailed description

Cohort study conducted in the United States \& United Kingdom to assess Oral Health Related Quality of Life (OHRQoL) in patients receiving the study polymer Removable Partial Denture (RPD) as compared to their baseline Cobalt Chrome (CoCr) Removable Partial Denture (RPD) Oral Health Quality of Life (OHRQoL).

Conditions

• Missing Teeth
• Dental Wear

Interventions

Type	Name	Description
DEVICE	Solvay Dental 360™	polymer Removable Partial Denture (RPD)

Timeline

• Start date: 2017-06-06
• Primary completion: 2019-10-07
• Completion: 2019-10-07
• First posted: 2017-06-26
• Last updated: 2020-11-19
• Results posted: 2020-11-02

Locations

2 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study