OHQoL With Removable Partial Dentures; a Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Missing Teeth
• Intervention / Treatment: Device: Dentures

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • Charles Clifford Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Juvora PEEK frameworks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient preference for type of denture	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
General quality of life	6 weeks

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Sheffield; Juvora Dental Solutions
• Investigators: Principal Investigator: Zaid Ali, BChD, Sheffield Teaching Hospitals NHS FT

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 11, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: STH18134