Clinical trial NCT01953991: OHQoL With Removable Partial Dentures; a Pilot Study
Official title: A Pilot Study Investigating Oral Health Related Quality of Life Improvements in Removable Partial Denture Treatments for the Replacement of Missing Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Partial Edentulism
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: Juvora Dental Solutions
First posted: 2013-10-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient preference for type of denture
timeFrame: 6 weeks
Secondary outcomes:
measure: General quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Charles Clifford Dental Hospital
Study officials:
affiliation: Sheffield Teaching Hospitals NHS FT
name: Zaid Ali, BChD
role: PRINCIPAL_INVESTIGATOR
References: