Clinical trial NCT03198520: REFRAME RPD Post-Market Clinical Study
Official title: REFRAME RPD Post-Market Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Dental Wear
Lead sponsor: Solvay Dental 360
Sponsor class: INDUSTRY
First posted: 2017-06-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient Oral Health-related Quality
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for Polymer Removable Partial Denture
Secondary outcomes:
measure: Comparison of Health of Abutment Teeth
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
measure: Operator Assessment
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and visits 5 (5 weeks), 6 (6 weeks), 7 (7 weeks) and 8 (8 weeks) for the Solvay Dental 360™: Polymer Removable Partial Denture
measure: Patient Frame Preference
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
measure: Review for Mechanical Failure
timeFrame: Approximately 8 weeks
measure: Operator Assessment of Pocket Depth
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
measure: Oral Health Parameters: Operator Assessment of Mobility:
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
measure: Oral Health Parameters: Mucosal Bearing Areas
timeFrame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Illinois Chicago College of Dentistry
state: Illinois
city: Leeds
country: United Kingdom
facility: Leeds School of Dentistry Unversity of Leeds
state: West Yorkshire
Study officials:
affiliation: Leeds School of Dentistry
name: Brian Natress, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois Chicago
name: Jiyeon Kim, DDS
role: PRINCIPAL_INVESTIGATOR
References: