Back to resultsREFRAME RPD Post-Market Clinical Study
Primary Purpose
Missing Teeth, Dental Wear
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Solvay Dental 360™
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth
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
Sites / Locations
- The University of Illinois Chicago College of Dentistry
- Leeds School of Dentistry Unversity of Leeds
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Polymer Removable Partial Denture
Arm Description
Evaluate the change in patient Oral Health-related Quality of Life while wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Comparison of Health of Abutment Teeth
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.
Operator Assessment
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.
Patient Frame Preference
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.
Review for Mechanical Failure
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."
Operator Assessment of Pocket Depth
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.
Oral Health Parameters: Operator Assessment of Mobility:
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.
Oral Health Parameters: Mucosal Bearing Areas
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03198520
Brief Title
REFRAME RPD Post-Market Clinical Study
Official Title
REFRAME RPD Post-Market Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solvay Dental 360
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth, Dental Wear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polymer Removable Partial Denture
Arm Type
Other
Arm Description
Evaluate the change in patient Oral Health-related Quality of Life while wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD)
Intervention Type
Device
Intervention Name(s)
Solvay Dental 360™
Intervention Description
polymer Removable Partial Denture (RPD)
Primary Outcome Measure Information:
Title
Change in Patient Oral Health-related Quality
Description
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.
Time Frame
Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for Polymer Removable Partial Denture
Secondary Outcome Measure Information:
Title
Comparison of Health of Abutment Teeth
Description
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.
Time Frame
Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
Title
Operator Assessment
Description
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.
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
Title
Patient Frame Preference
Description
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.
Time Frame
Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
Title
Review for Mechanical Failure
Description
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."
Time Frame
Approximately 8 weeks
Title
Operator Assessment of Pocket Depth
Description
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.
Time Frame
Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
Title
Oral Health Parameters: Operator Assessment of Mobility:
Description
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.
Time Frame
Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
Title
Oral Health Parameters: Mucosal Bearing Areas
Description
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.
Time Frame
Baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and 8 weeks for the Solvay Dental 360™: Polymer Removable Partial Denture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Natress, DDS
Organizational Affiliation
Leeds School of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiyeon Kim, DDS
Organizational Affiliation
University of Illinois Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Illinois Chicago College of Dentistry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Leeds School of Dentistry Unversity of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS290AY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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REFRAME RPD Post-Market Clinical Study
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