Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2014-05-31
2017-09-30
Brief Summary
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RPDs are made out of a framework and the replacement teeth/gum. The framework sits on the teeth and the gums and can be made out of different materials, metal or non-metal, with different properties. The plastic teeth and gum sit on the framework.
A common framework material is cobalt chromium, a rigid, non-precious metal alloy. Other framework materials include titanium and non-metal materials such as medical grade polyetheretherketone (PEEK).
A review of the literature shows that no research has been reported investigating how different RPD framework materials impact on a person's oral health related quality of life (OHQoL). The sensation that different frameworks have in the mouth can be quite varied between people, and it would be relevant to be able to tell patients which type of framework is better tolerated based on research evidence.
We hope to conduct an un-blinded randomised crossover pilot trial investigating the difference in patient preference and oral health related quality of life measured by patient centred outcomes in a group of patients due to receive tooth supported removable partial dentures at the Charles Clifford Dental Hospital.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Cobalt chrome dentures
Cobalt chrome dentures are used as part of standard care for patients
Dentures
Removable prosthesis to replace missing teeth
PEEK dentures
PEEK dentures will be used as a comparator denture for patients
Dentures
Removable prosthesis to replace missing teeth
Interventions
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Dentures
Removable prosthesis to replace missing teeth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with the absence of 3 or more teeth, excluding third molars, per jaw arch,
* with or without previous denture wearing experience, and
* 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.
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.
18 Years
ALL
Yes
Sponsors
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University of Sheffield
OTHER
Juvora Dental Solutions
UNKNOWN
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Zaid Ali, BChD
Role: PRINCIPAL_INVESTIGATOR
Sheffield Teaching Hospitals NHS FT
Locations
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Charles Clifford Dental Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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STH18134
Identifier Type: -
Identifier Source: org_study_id