REFRAME RPD Post-Market Clinical Study

Completed · Not applicable

Conditions studied: Missing Teeth, Dental Wear

In brief

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.

Key facts

Study ID

NCT03198520

Run by

Solvay Dental 360

People needed

46

Starts

2017-06-06

Expected to finish

2019-10-07

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• with the absence of 3 or less teeth per saddle, excluding third molars
• partial denture in one arch only
• with previous denture wearing experience, and Cobalt Chrome (CoCr) Removable Partial Denture (RPD) fitted in the previous 24 months and the patient is currently and routinely wearing the denture
• With a stable oral health in terms of absence of disease activity affecting the periodontium, dental hard tissues (caries), pulp and the structural/aesthetic integrity of restored teeth
• With at least 1 posterior natural tooth occlusal stop (molar or premolar)
• Class I, Class II and Class III (Kennedy's Classification)
• Occlusal spacing (static and dynamic) around clasp assembly including the occlusal rest

You may not qualify if…

• Patients requiring extensive treatment prior to the provision of a removable partial denture (RPD)
• Patients with active primary disease; caries, periodontal disease or symptoms of pulpal or apical pathology to the remaining teeth
• Patients with irreversibly compromised structural/aesthetic integrity of restored teeth that cannot be restored as part of the provision of treatment.
• Patients with an opposing Removable Partial Denture (RPD). Removable Partial Denture (RPD) to only be in one arch and must oppose a full denture or a dentate arch which provides a stable occlusal relationship
• Canines are NOT to be replaced with the Removable Partial Denture's (RPDs). Patients must have their natural canines present

Where it is running

• The University of Illinois Chicago College of Dentistry — Chicago, Illinois, United States
• Leeds School of Dentistry Unversity of Leeds — Leeds, West Yorkshire, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.