REFRAME RPD Post-Market Clinical Study

NCT03198520 | Completed Results FDA Device

• 1 other identifier: DS002
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 2

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.

Conditions

Missing Teeth; Dental Wear

Outcome Measures

Primary Outcomes (1)

• Change in Patient Oral Health-related Quality

  Subjects conducted the Oral Health-related Quality of Life (OHRQoL) before and after wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD). OHRQoL is a multidimensional survey which can be defined as a person's assessment of how functional, psychological, social factors, pain, or discomfort affect his/her well-being in the context of oral health. The purpose of the survey is to evaluate the change in these factors from wearing a cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD). This score is calculated by a summation of the score from each question; each having the following scoring: Response Score Never 0 Points Hardly Ever 1 Point Occasionally 2 Points Fairly Often 3 Points Very Often 4 Points It ranges from 0 to 56 points. The overall scores are from the baseline Cobalt Chrome (CoCr) RPD and 8 weeks for Polymer RPD. Lower scores are better outcomes.

  Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for Polymer Removable Partial Denture

Secondary Outcomes (7)

• Comparison of Health of Abutment Teeth

  Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture

• Operator Assessment

  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

• Patient Frame Preference

  Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture

• Review for Mechanical Failure

  Approximately 8 weeks

• Operator Assessment of Pocket Depth

  Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture

Study Arms (1)

Polymer Removable Partial Denture

OTHER

Evaluate the change in patient Oral Health-related Quality of Life while wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD)

Device: Solvay Dental 360™

Interventions

Solvay Dental 360™ DEVICE

polymer Removable Partial Denture (RPD)

Polymer Removable Partial Denture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Solvay Dental 360: lead

Study Sites (2)

The University of Illinois Chicago College of Dentistry

Chicago, Illinois, 60612, United States

Location

Leeds School of Dentistry Unversity of Leeds

Leeds, West Yorkshire, LS290AY, United Kingdom

Location

MeSH Terms

Conditions

Anodontia; Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Tim Shary Compliance and Product Specialist
• Organization: Solvay® Dental 360

Tim.shary@solvay.com

770-772-8665

Study Officials

• Brian Natress, DDS

  Leeds School of Dentistry

  PRINCIPAL INVESTIGATOR

• Jiyeon Kim, DDS

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: June 26, 2017
• Study Start: June 6, 2017
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1)