Dentures produced by 3D printing Oral Health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Edentulous 2. Available for follow-up 3. Requires replacement complete dentures 4. Able and willing to complete the informed consent process. 5. Aged 18 years or over at the time of signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. Oral tumour 2. Denture stomatitis 3. Requires an obturator 4. Extreme xerostomia (e.g. Sjögren's syndrome) 5. Known hypersensitivity to dental materials used in the research 6. Incapable of written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant's preference of denture assessed at Study Clinical Visit 5 and analysed using McNemar's test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinician's assessment of the retention of the 3-D printed denture bases at jaw registration (Study Clinical Visit 3) and denture fit (Study Clinical Visit 5) using a 5-point Likert scale 2. Clinician's assessment of the stability of the 3-D printed denture bases at jaw registration (Study Clinical Visit 3) and denture fit (Study Clinical Visit 5) using a 5-point Likert scale 3. Clinicians preference for the base plate of the jaw registration blocks with options for 'no preference - both satisfactory' and 'no preference - both unsatisfactory' at jaw registration (Study Clinical Visit 3) 4. Patient assessment of the finished dentures for comfort using a 5-point Likert scale at denture fit (Study Clinical Visit 5) 5. Patient assessment of the finished dentures for stability using a 5-point Likert scale at denture fit (Study Clinical Visit 5) 6. Patient assessment of the finished dentures for aesthetics using a 5-point Likert scale at denture fit (Study Clinical Visit 5) 7. Reason given by the participant for their preferences for the dentures assessed using an open-ended question at denture fit (Study Clinical Visit 5)(to be analysed qualitatively) 8. Participant's opinion of the aesthetics of the dentures assessed using an open-ended question at denture fit (Study Clinical Visit 5) (to be analysed qualitatively) | — |
Countries
United Kingdom