OHQoL With Removable Partial Dentures; a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study Investigating Oral Health Related Quality of Life Improvements in Removable Partial Denture Treatments for the Replacement of Missing Teeth

Conditions
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Missing Teeth, Partial Edentulism

Intervention / Treatment
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* Device: Dentures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cobalt chrome dentures<br>Cobalt chrome dentures are used as part of standard care for patients | Device: Dentures<br>* Removable prosthesis to replace missing teeth<br>* Other names: Juvora PEEK frameworks;|
| Active Comparator: PEEK dentures<br>PEEK dentures will be used as a comparator denture for patients | Device: Dentures<br>* Removable prosthesis to replace missing teeth<br>* Other names: Juvora PEEK frameworks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference for type of denture |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General quality of life |  | 6 weeks |