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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01953991
Other study ID # STH18134
Secondary ID
Status Completed
Phase N/A
First received September 26, 2013
Last updated November 22, 2017
Start date May 2014
Est. completion date September 30, 2017

Study information

Verified date November 2017
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 30, 2017
Est. primary completion date January 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Dentures
Removable prosthesis to replace missing teeth

Locations

Country Name City State
United Kingdom Charles Clifford Dental Hospital Sheffield

Sponsors (3)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust Juvora Dental Solutions, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient preference for type of denture 6 weeks
Secondary General quality of life 6 weeks
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