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REFRAME RPD Post-Market Clinical Study

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ClinicalTrials.gov Identifier: NCT03198520
Recruitment Status : Completed
First Posted : June 26, 2017
Results First Posted : November 2, 2020
Last Update Posted : November 19, 2020
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)
Actual Enrollment : 46 participants
Allocation: N/A
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
Actual Primary Completion Date : October 7, 2019
Actual Study Completion Date : October 7, 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: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for Polymer Removable Partial Denture ]

    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.



Secondary Outcome Measures :
  1. Comparison of Health of Abutment Teeth [ Time Frame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture ]

    To investigate the difference in health of the abutment teeth following the use of the polymer RPD as compared to the CoCr RPD as assessed by the plaque score and gingival bleeding index.

    The plaque score is determined by assessing each tooth and the amount of plaque on the individual surfaces. The total number of plaque containing surfaces is divided by the total number of surfaces per arch of the mouth.

    Arch plaque is a subset of the whole plaque score calculated as the number of arch surfaces with plaque divided by the number of arch surfaces assessed.

    The gingival bleeding index is a designation of the degree of inflammation, as determined by a "bleeding on probing" assessment. Each tooth is probed at six sites and the bleeding is scored as present or absent. The number of sites where the bleeding is noted is divided by the total number of surfaces evaluated.

    All assessments are expressed as a percentage and an increased percentage indicates a poorer patient outcome.


  2. Operator Assessment [ Time Frame: 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 ]

    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. This assessment was done with a Likert scale at baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and visits 5, 6, 7 and 8 for the Solvay Dental 360™: Polymer Removable Partial Denture.

    This assessment of aesthetics was determined by the operator based on a five point scale rating from very dissatisfied through very satisfied. More satisfied is a better outcome.


  3. Patient Frame Preference [ Time Frame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture ]

    Patient-centered assessment of preference at the final visit for the study.

    Patients were asked to choose their preference of Removable Partial Denture based on comfort, aesthetics and chewing. Preference for a specific denture is a better outcome.


  4. Review for Mechanical Failure [ Time Frame: Approximately 8 weeks ]

    This is an evaluation of the Solvay Dental 360™ Polymer Removable Partial Denture (RPD) for chips, cracks, fractures, permanent deformation or other signs mechanical failure. The number in the reported data represents a cumulative number of Solvay Dental 360™Polymer Removable Partial Denture (RPD) devices with these mechanical failures.

    A device deficiency was defined as "the inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance."


  5. Operator Assessment of Pocket Depth [ Time Frame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture ]

    Oral Health parameters associated with the Removable Partial Denture (RPD) on pocket depths based on Operator assessment.

    Pocket depths are expressed in mm increments for mesial, mid, and distal locations on the lingual and buccal surfaces of the tooth. To measure pocket depth, a probe is placed beside the tooth beneath the gumline and indicates the groove between the gums and teeth. Visit 2 with the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) is compared to visit 8 with the Solvay Dental 360™: Polymer Removable Partial Denture. In general, pocket depths of 1 to 3 mm indicate a healthy mouth and 4mm and greater may indicate periodontitis. The score is calculated as an average of all depths reported for all surfaces assessed.

    A lower score is a better outcome.


  6. Oral Health Parameters: Operator Assessment of Mobility: [ Time Frame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture ]

    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).

    Mobility of the teeth abutting the missing tooth as well as adjacent to the abutment tooth are classified via the Miller Classification as the following:

    • Class I: Tooth can be moved less than 1mm in the buccolingual or mesiodistal direction; this included no mobility
    • Class II: Tooth can be moved 1mm or more in the buccolingual or mesiodistal direction. No mobility in the occlusoapical direction (vertical mobility)
    • Class III: Tooth can be moved 1mm or more in the buccolingual or mesiodistal direction. Mobility in the occlusoapical direction is also present

    The mobility score assessment is noted as proportion of teeth that moved from a lower classification to a higher classification. Class I is a better outcome.


  7. Oral Health Parameters: Mucosal Bearing Areas [ Time Frame: Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture ]

    Oral Health parameters associated with the Solvay Dental 360™ 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", as compared to the Cobalt Chrome (CoCr) Removable Partial Denture (RPD).

    Operators were asked to rate the health of the mucosal bearing areas as poor, fair or good. The mucosal bearing area is the cushion between the denture base and the supporting bone. Good is a better outcome.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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United States, Illinois
The University of Illinois Chicago College of Dentistry
Chicago, Illinois, United States, 60612
United Kingdom
Leeds School of Dentistry Unversity of Leeds
Leeds, West Yorkshire, United Kingdom, LS290AY
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
  Study Documents (Full-Text)

Documents provided by Solvay Dental 360:
Study Protocol  [PDF] July 27, 2018
Informed Consent Form  [PDF] May 3, 2018
Statistical Analysis Plan  [PDF] March 5, 2019

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Responsible Party: Solvay Dental 360
ClinicalTrials.gov Identifier: NCT03198520    
Other Study ID Numbers: DS002
First Posted: June 26, 2017    Key Record Dates
Results First Posted: November 2, 2020
Last Update Posted: November 19, 2020
Last Verified: November 2020
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: Yes
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