OHQoL With Removable Partial Dentures; a Pilot Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborators:
University of Sheffield
Juvora Dental Solutions
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01953991
First received: September 26, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  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: Removable partial dentures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cobalt chrome dentures
Standard care
Device: Removable partial dentures
Removable prosthesis to replace missing teeth
Other Name: Juvora PEEK frameworks
Active Comparator: PEEK dentures
Non-standard dentures
Device: Removable partial dentures
Removable prosthesis to replace missing teeth
Other Name: Juvora PEEK frameworks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953991

Contacts
Contact: Zaid Ali, BChD 0114 2717921 zaid.ali@sth.nhs.uk
Contact: Nicolas Martin, BDS n.martin@sheffield.ac.uk

Locations
United Kingdom
Charles Clifford Dental Hospital Not yet recruiting
Sheffield, United Kingdom
Contact: Zaid Ali, BChD         
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

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01953991     History of Changes
Other Study ID Numbers: STH18134
Study First Received: September 26, 2013
Last Updated: September 26, 2013
Health Authority: SheffieldNHSTrust,UK:

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

ClinicalTrials.gov processed this record on August 28, 2014