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OHQoL With Removable Partial Dentures; a Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01953991
First Posted: October 1, 2013
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Sheffield
Juvora Dental Solutions
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
  Purpose

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.


Condition Intervention
Missing Teeth Partial Edentulism Device: Dentures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating Oral Health Related Quality of Life Improvements in Removable Partial Denture Treatments for the Replacement of Missing Teeth

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Patient preference for type of denture [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • General quality of life [ Time Frame: 6 weeks ]

Enrollment: 25
Study Start Date: May 2014
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cobalt chrome dentures
Cobalt chrome dentures are used as part of standard care for patients
Device: Dentures
Removable prosthesis to replace missing teeth
Other Name: Juvora PEEK frameworks
Active Comparator: PEEK dentures
PEEK dentures will be used as a comparator denture for patients
Device: Dentures
Removable prosthesis to replace missing teeth
Other Name: Juvora PEEK frameworks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953991


Locations
United Kingdom
Charles Clifford Dental Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Juvora Dental Solutions
Investigators
Principal Investigator: Zaid Ali, BChD Sheffield Teaching Hospitals NHS FT
  More Information

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01953991     History of Changes
Other Study ID Numbers: STH18134
First Submitted: September 26, 2013
First Posted: October 1, 2013
Last Update Posted: May 15, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities