OHQoL With Removable Partial Dentures; a Pilot Study
Primary Purpose
Missing Teeth, Partial Edentulism
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dentures
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth
Eligibility Criteria
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.
Sites / Locations
- Charles Clifford Dental Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cobalt chrome dentures
PEEK dentures
Arm Description
Cobalt chrome dentures are used as part of standard care for patients
PEEK dentures will be used as a comparator denture for patients
Outcomes
Primary Outcome Measures
Patient preference for type of denture
Secondary Outcome Measures
General quality of life
Full Information
NCT ID
NCT01953991
First Posted
September 26, 2013
Last Updated
November 22, 2017
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield, Juvora Dental Solutions
1. Study Identification
Unique Protocol Identification Number
NCT01953991
Brief Title
OHQoL With Removable Partial Dentures; a Pilot Study
Official Title
A Pilot Study Investigating Oral Health Related Quality of Life Improvements in Removable Partial Denture Treatments for the Replacement of Missing Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 11, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield, Juvora Dental Solutions
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth, Partial Edentulism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cobalt chrome dentures
Arm Type
Active Comparator
Arm Description
Cobalt chrome dentures are used as part of standard care for patients
Arm Title
PEEK dentures
Arm Type
Active Comparator
Arm Description
PEEK dentures will be used as a comparator denture for patients
Intervention Type
Device
Intervention Name(s)
Dentures
Other Intervention Name(s)
Juvora PEEK frameworks
Intervention Description
Removable prosthesis to replace missing teeth
Primary Outcome Measure Information:
Title
Patient preference for type of denture
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
General quality of life
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaid Ali, BChD
Organizational Affiliation
Sheffield Teaching Hospitals NHS FT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles Clifford Dental Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
OHQoL With Removable Partial Dentures; a Pilot Study
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