Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2017-06-06
2019-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
Solvay Dental 360™
polymer Removable Partial Denture (RPD)
Interventions
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Solvay Dental 360™
polymer Removable Partial Denture (RPD)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Solvay Dental 360
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Natress, DDS
Role: PRINCIPAL_INVESTIGATOR
Leeds School of Dentistry
Jiyeon Kim, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Illinois Chicago
Locations
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The University of Illinois Chicago College of Dentistry
Chicago, Illinois, United States
Leeds School of Dentistry Unversity of Leeds
Leeds, West Yorkshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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DS002
Identifier Type: -
Identifier Source: org_study_id