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REFRAME RPD Post-Market Clinical Study

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ClinicalTrials.gov Identifier: NCT03198520
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Solvay Dental 360

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.

Condition or disease Intervention/treatment Phase
Missing Teeth Dental Wear Device: Solvay Dental 360™ Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REFRAME RPD Post-Market Clinical Study
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Polymer Removable Partial Denture
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™
polymer Removable Partial Denture (RPD)




Primary Outcome Measures :
  1. Change in Patient Oral Health-related Quality [ Time Frame: Approximately 8 weeks ]
    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 360™ polymer Removable Partial Denture (RPD). Being compared from visit 2 to visit 8.


Secondary Outcome Measures :
  1. Comparison of Health of Abutment Teeth [ Time Frame: Approximately 8 weeks ]
    Comparison of the health of the abutment teeth during/following the use of the polymer Removable Partial Denture (RPD) as compared to Cobalt Chrome (CoCr) Removable Partial Denture (RPD) as compared to the Cobalt Chrome )CoCr) Removable Partial Denture (RPD) as assessed by the arch plaque score and gingival bleeding index.

  2. Operator Assessment [ Time Frame: 8 weeks ]
    Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium. Assessed via a Likert scale at visits 5, 6, 7 and 8.

  3. Patient Centered Assessment [ Time Frame: Approximately 8 weeks ]
    Patient-centered assessment of comfort, aesthetics and chewing ability before and after construction of the new denture by a 5 point Likert scale that is conducted at visits 2, 5 and 8.

  4. Review for Mechanical Failure [ Time Frame: Approximately 8 weeks ]
    • Evaluation and photographic documentation of the Polymer Removable Partial Denture (RPD) for cracks, fractures, permanent deformation or other signs mechanical failure

  5. Oral Health Parameters [ Time Frame: Approximately 8 weeks ]
    Oral Health parameters associated with the Removable Partial Denture (RPD) abutment teeth probing depths and mobility (measured in millimeters)

  6. Oral Health Parameters [ Time Frame: Approximately 8 weeks ]
    Oral Health parameters associated with the Removable Partial Denture (RPD) abutment teeth and Removable Partial Denture (RPD): mobility (measured as a categorical value of either Class I, Class II or Class III.

  7. Oral Health Parameters [ Time Frame: Approximately 8 weeks ]
    Oral Health parameters associated with the Removable Partial Denture (RPD): mucosal bearing areas (measured as an evaluation of bleeding on probing indicated as a categorical value of "bleeding present" or "bleeding absent"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198520


Contacts
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Contact: Pamela Wolfe 763-258-7027 pwolfe@namsa.com

Locations
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United States, Illinois
The University of Illinois Chicago College of Dentistry Recruiting
Chicago, Illinois, United States, 60612
Contact: Jiyeon Kim, DDS    312-996-9486      
United Kingdom
Leeds School of Dentistry Unversity of Leeds Recruiting
Leeds, West Yorkshire, United Kingdom, LS290AY
Contact: Brian Natress, DDS    +44 00113 34 36197      
Sponsors and Collaborators
Solvay Dental 360
Investigators
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Principal Investigator: Brian Natress, DDS Leeds School of Dentistry
Principal Investigator: Jiyeon Kim, DDS University of Illinois Chicago

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Responsible Party: Solvay Dental 360
ClinicalTrials.gov Identifier: NCT03198520     History of Changes
Other Study ID Numbers: DS002
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Tooth Wear
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities