Clinical Outcomes of 3D Printed and Milled Complete Dentures

Restorations still in function after 3 and 6 months, and 2, 3, 4 and 5 years.

A denture will be considered successful if all the following criteria are fulfilled:

Absence of major technical complications.

Absence of major biological complications.

Functional occlusion and mastication, assessed by clinical examination and OHIP-EDENT.

• Assessed by OHIP-EDENT - Q1 from OHIP: "Have you had difficulty chewing any foods because of problems with your teeth, mouth or dentures?", where score 0-2 would be considered successful (0=never, 1=hardly ever, 2 = occasionally).

Absence of patient reported discomfort, assessed by OHIP-EDENT.

• Assessed by all questions in Physical pain section of OHIP-EDENT - Q4 "Have you had painful aching in your mouth?", Q5 "Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?", Q6 "Have you had sore spots in your mouth?, Q7 "Have you had uncomfortable dentures?", where score 0-1 would be considered successful (0=never and 1=hardly ever).

Evaluation of accuracy of 3D printing and milling technology will be made using Geomagic Software at time of final denture insertion. The denture intaglio at insertion will be compared with the final impression as reference scan.

Retention force of the dentures will be evaluated by applying a dynamometer gauge at the following locations: Post dam, Tuberosities and retromolar pads.

Complications will be recorded and assessed as either:

• Major complications (requiring laboratory intervention to correct - fracture, lab reline, etc.).
• Minor complications (requiring chairside adjustment - sore spots, occlusal discrepancies, etc.).

Occurrence of biological complications. Biological complications will be evaluated by recording major and minor biological complications. The evaluation of biological complications will be derived from the adverse event (AE)/adverse device effect (ADE) sections of the Case Report Form.

Quality of Life through Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) Questionnaire completed by participating subjects. OHIP-EDENT contains 19 questions, divided into six domains: Functional limitations, Physical pain, Psychological discomfort, Physical disability, Psychological disability and Handicap. Response categories for all questions: 4 = very often; 3 = fairly often; 2 = occasionally; 1 = hardly ever; 0=never, i.e. lower scores corresponds with higher quality of life.

Patient satisfaction including aesthetics as evaluated by patient questionnaire including the following questions:

1. Are you overall satisfied with your dentures?
2. Are your satisfied with the comfort of your dentures?
3. Are you satisfied with the aesthetics of your dentures?
4. Are you satisfied with your ability to speak when wearing your dentures?
5. Are you satisfied with the fit of your dentures?

Patient satisfaction with dentures will be evaluated using a likert scale, ranging from 0 to 10 for each of above questions. The likert scale representing a spectrum of feelings between extremes with 0= Very unsatisfied and 10= Very satisfied. Patients will rate their assessment by marking a number corresponding to their feelings at the time. A low score represents a high degree of dissatisfaction, and a high score a high degree of satisfaction

Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Volumetric loss measured in mm3.

Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Maximum vertical loss measured in μm.

Discolouration (intrinsic or interfacial) measured with spectrophotometer. The colour at a central incisor (#8) and the denture just above #8 will be measured.

Number of occlusal contacts using articulating paper will be documented.

Appropriateness of tooth shape assessed by the following Yes/No question:

Appropriate Tooth Shape to match facial aesthetics?

Appropriateness of tooth size assessed by the following Yes/No question:

Appropriate Tooth Size to match facial aesthetics?

Appropriateness of tooth arrangements assessed by the following Yes/No questions:

• Overall tooth position, angulation and alignment that appears natural and pleasing?
• Posterior tooth alignment to maintain adequate buccal corridors?
• Dental midline aligned in relation to facial midline?
• Appropriate orientation of occlusal plane in relation to patient's smile line and facial reference lines?
• Sufficient horizontal overlap?

Appropriateness of tooth colour /colour match assessed by the following Yes/No questions:

• Appropriate Tooth Shade to suit the naturalness of the patient's skin tone?
• Appropriate Gingival Shade, translucency and colour characterisation to suit the naturalness of the patient's original gingiva?

Appropriateness of denture base assessed by the following Yes/No questions:

• Appropriate tooth to gingival display?
• Appropriate physical characterisation (contours) of denture base that appears natural and pleasing?

Lip support assessed by the following Yes/No questions:

• Anterior tooth alignment to provide adequate lip support when viewed from the facial profile?
• Appropriate arch form to allow for natural facial expressions and phonetics?
• Thickness of denture flange for adequate lip support and facial expressions?

Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.