OHQoL With Removable Partial Dentures; a Pilot Study

Not Applicable

Completed

• Conditions: Missing Teeth; Partial Edentulism
• Interventions: Device: Dentures

• Registration Number: NCT01953991
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Study Start: 2014-05
• Primary Completion: 2017-01-11
• Study Completion: 2017-09-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PEEK dentures	Dentures	PEEK dentures will be used as a comparator denture for patients
Cobalt chrome dentures	Dentures	Cobalt chrome dentures are used as part of standard care for patients

Primary Outcome Measures

Name	Time	Method
Patient preference for type of denture	6 weeks

Secondary Outcome Measures

Name	Time	Method
General quality of life	6 weeks

Trial Locations

Locations (1)

Charles Clifford Dental Hospital; 🇬🇧 Sheffield, United Kingdom