OHQoL With Removable Partial Dentures; a Pilot Study

Missing Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953991
• Other study ID #: STH18134
• 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
• 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.

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Partial Edentulism
• Tooth Loss

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