N/A
N=46
REFRAME RPD Post-Market Clinical Study
Missing Teeth · Dental Wear
Bottom Line
View on ClinicalTrials.gov: NCT03198520 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change in Patient Oral Health-related Quality — 9.01; 14.41 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Solvay Dental 360™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solvay Dental 360
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Oral Health-related Quality |
9.01; 14.41 | — |
| SECONDARY Comparison of Health of Abutment Teeth |
36.48; 39.42; 37.39; 39.87; 16.33; 20.40 | — |
| SECONDARY Operator Assessment |
1; 1; 0; 0; 0; 5 | — |
| SECONDARY Patient Frame Preference |
32; 8 | — |
| SECONDARY Review for Mechanical Failure |
2; 1; 1; 14; 1; 1 | — |
| SECONDARY Operator Assessment of Pocket Depth |
2.19; 2.23 | — |
| SECONDARY Oral Health Parameters: Operator Assessment of Mobility: |
211; 221; 7; 11; 1; 1 | — |
| SECONDARY Oral Health Parameters: Mucosal Bearing Areas |
36; 40; 4; 4; 0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03198520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.