REFRAME RPD Post-Market Clinical Study

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).

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