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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01953991
Enrollment
25
Registered
2013-10-01
Start date
2014-05-31
Completion date
2017-09-30
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Missing Teeth, Partial Edentulism

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.

Interventions

DEVICEDentures

Removable prosthesis to replace missing teeth

Sponsors

University of Sheffield
CollaboratorOTHER
Juvora Dental Solutions
CollaboratorUNKNOWN
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Patient preference for type of denture6 weeks

Secondary

MeasureTime frame
General quality of life6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026