REFRAME RPD Post-Market Clinical Study

Solvay

Status

Completed

Conditions

Dental Wear

Missing Teeth

Treatments

Device: Solvay Dental 360™

Study type

Interventional

Funder types

Industry

Identifiers

NCT03198520

DS002

Details and patient eligibility

About

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.

Full 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).

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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