Preference for type of dentures Oral Health
Conditions
Interventions
In conjunction with their integrated PPI group, the research team developed the “IMPROVDENT” RCT protocol for the patient-centred assessment of two sets of dentures. The PPI group consists of patients
it has proved sufficiently sensitive and specific to detect clinically and statistically significant differences in patient-centred RCTs of dentures. In order to be able to calculate the sample size r
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who: 1. Have no natural teeth 2. Are available for follow up 3. Require replacement complete dentures 4. Are able and willing to complete the informed consent process 5. Are aged over 60 years at the time of signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Patients who: 1. Have (or have had) an oral tumour 2. Require an obturator 3. Have extreme xerostomia (e.g. Sjögren's syndrome) 4. Have a denture stomatitis 5. Have known hypersensitivity to dental materials used in the research 6. Are incapable of providing written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's preference for the dentures measured using a participant questionnaire (non-validated) at the clinical visit which occurs 2 weeks after delivering both sets of dentures | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant preference for the unadjusted dentures measured using a non-validated participant preference assessment of dentures questionnaire at visit 6 2. Participant preference after the dentures have been fully adjusted measured using a non-validated participant preference assessment of dentures questionnaire at visit 9 3. Participant assessment of comfort, stability and chewing ability of each of the dentures, before and after each adjustment period measured using a 5-point Likert assessment questionnaire (visits 6, 7, 8 & 9) 4. Oral Health-Related Quality of Life (OHRQoL) assessed using an established and validated OHIP-Edent questionnaire at the 1st impression visit and at the end of each adjustment period (visits 1, 7 & 8) | — |
Countries
England, United Kingdom
Outcome results
None listed