Optimizing clinical workflows for 3-D printed dentures

INTERVENTION: A prospective cohort study of 20 patient participants is proposed. In order to gain the maximum input from experienced clinicians, this preliminary study is taking place in 3 centers of excellence within leading UK Dental Schools (Manchester, Birmingham and Leeds). We will recruit 20 participants (at least 6 at each centre) for this preliminary work. The case series will look at alternative clinical workflows and come to a consensus opinion of the best way to produce 3‐D printed dentures. Patients who are attending one of the three Dental Schools will be approached and asked if they wish to take part in a research project. If they express an interest in participation they will be informed of the study and given a Participant Information Sheet (PIS) which provides details of the project. At Study Clinical Visit 1 (at least 24 h later) they will be asked if they have any questions about the research, and, after a conversation and discussion, if they wish to take part in the project. If they wish to participate they will be asked to sign the written consent form. Following consent they will proceed with the routine clinical stages of denture production; moving on directly to primary impressions at Study Clinical Visit 1. The primary impressions will follow the normal clinical routine. The participants will be randomised using computer‐generated block randomisation to one of three different strategies for producing the scan used to design the dentures. At Study Clinical Visit 2, the patient will have the normal definitive impression taken using a standardized procedure. Following the definitive impression, after the participant has left the clinic, the impressions will be optically scanned to produce a 3‐D digital 'ma CONDITION: Dentures produced by 3D printing ; Oral Health PRIMARY OUTCOME: Participant's preference of denture assessed at Study Clinical Visit 5 and analysed using McNemar's test SECONDARY OUTCOME: ; 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); 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