Improving dentures for patient benefit

Not Applicable

Completed

Conditions: Quality of denture production
Not Applicable
Fitting and adjustment of other devices

Registration Number: ISRCTN01528038

Lead Sponsor: niversity of Leeds (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 85

Inclusion Criteria

1. Patients of either sex who are edentulous
2. Subject is available for follow up
3. Subject requires replacement complete dentures
4. Subject is able and willing to sign the Informed Consent Form
5. Aged 18 years or over at the time of signing the Informed Consent Form

Exclusion Criteria

1. Presence of an oral tumour
2. Requirement for an obturator
3. Extreme xerostomia (e.g. Sjogren's Syndrome)
4. Patients who would benefit from selective pressure impressions
5. Known hypersensitivity to silicone or alginate

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient preference for unadjusted dentures and overall cost-effectiveness, measured at the end of the habituation period. Patient preference will be established by asking whether one or other denture is preferred, or whether there is no preference. Those expressing no preference will be further asked whether both dentures were satisfactory or unsatisfactory.

Secondary Outcome Measures

Name	Time	Method
Measured at the end of the secondary impressions, habituation, adjustment and confirmation periods:<br>1. Comfort, Mobility, Chewing Efficiency using 5-point Likert Scales<br>2. Oral Health-Related Quality of Life using OHIP-EDENT<br>3. Patient preference for adjusted dentures<br>4. Patient perception of comfort, taste and ease of use of each impression material using a 5-point Likert scale<br>5. Qualitative interviews to gain insight into the impact of oral health status on daily lives<br><br>Patient preference for adjusted dentures will be established by asking whether one or other denture is preferred, or whether there is no preference. Those expressing no preference will be further asked whether both dentures were satisfactory or unsatisfactory. Patients will be asked to reflect on the whole process of receiving the final denture (including initial comfort, amount of adjustment needed) when expressing preference.