OHQoL With Removable Partial Dentures; a Pilot Study

NCT01953991 | Completed

• 1 other identifier: STH18134
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth; Partial Edentulism

Outcome Measures

Primary Outcomes (1)

• Patient preference for type of denture

  6 weeks

Secondary Outcomes (1)

• General quality of life

  6 weeks

Study Arms (2)

Cobalt chrome dentures

ACTIVE COMPARATOR

Cobalt chrome dentures are used as part of standard care for patients

Device: Dentures

PEEK dentures

ACTIVE COMPARATOR

PEEK dentures will be used as a comparator denture for patients

Device: Dentures

Interventions

Dentures DEVICE

Removable prosthesis to replace missing teeth

Also known as: Juvora PEEK frameworks

Cobalt chrome dentures; PEEK dentures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator
• Juvora Dental Solutions: collaborator

Study Sites (1)

Charles Clifford Dental Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Anodontia

Interventions

Dentures

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Zaid Ali, BChD

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: May 1, 2014
• Primary Completion: January 11, 2017
• Study Completion: September 30, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

GB (1)