- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01953991
OHQoL With Removable Partial Dentures; a Pilot Study
A Pilot Study Investigating Oral Health Related Quality of Life Improvements in Removable Partial Denture Treatments for the Replacement of Missing Teeth
Removable false teeth (called removable partial dentures (RPDs)) are commonly made for people with missing teeth.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sheffield, United Kingdom
- Charles Clifford Dental Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adults from age 18 upwards:
- 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 requiring extensive treatment prior to the provision of a removable partial denture.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cobalt chrome dentures
Cobalt chrome dentures are used as part of standard care for patients
|
Removable prosthesis to replace missing teeth
Other Names:
|
Active Comparator: PEEK dentures
PEEK dentures will be used as a comparator denture for patients
|
Removable prosthesis to replace missing teeth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient preference for type of denture
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
General quality of life
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zaid Ali, BChD, Sheffield Teaching Hospitals NHS FT
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH18134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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