Clinical trial to evaluate 3D-printed dentures
Not Applicable
Completed
- Conditions
- Preference for type of denturesOral Health
- Registration Number
- ISRCTN17073439
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Participant preference for the unadjusted dentures measured using a non-validated participant preference assessment of dentures questionnaire at visit 6<br>2. Participant preference after the dentures have been fully adjusted measured using a non-validated participant preference assessment of dentures questionnaire at visit 9<br>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)<br>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)