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This is a two-armed, single-center clinical study evaluating performance, efficacy and safety of three dimensional (3D) printed complete dentures and milled complete dentures during a 5-year follow-up period. The primary objective of this clinical investigation is to evaluate survival rate, i.e. subjects with survived dentures in both upper and lower jaw, of 3D printed complete dentures and milled complete dentures after 1 year (in each of the groups separately).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed dentures | Experimental | 3D printed denture bases and 3D printed denture teeth. |
|
| Milled dentures | Experimental | Milled denture bases and denture teeth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucitone Digital Print | Device | Consisting of the following parts:
|
| Measure | Description | Time Frame |
|---|---|---|
| Denture survival rate | Restorations still in function after 1 year. | One year after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Denture survival rate | Restorations still in function after 3 and 6 months, and 2, 3, 4 and 5 years. | 3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture success |
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Inclusion Criteria:
Exclusion Criteria:
Known allergy or hypersensitivity to any of the components.
Subjects with significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6 ).
Known pregnancy at time of enrolment.
Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
Previous enrolment in the present clinical investigation.
Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
PDI Completely edentulous classification (Class 4)
Uncontrolled pathological process in the oral cavity, as judged by the Investigator.
Participation in another clinical investigation that may interfere with the present clinical investigation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ada Saltarski | Contact | +46 725568088 | ada.saltarski@dentsplysirona.com | |
| Ulrika Bonander | Contact | +46 313763068 | ulrika.bonander@dentsplysirona.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adams School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D007571 | Jaw Diseases |
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| Lucitone Digital Fit | Device | Consisting of the following parts:
|
|
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.
Absence of patient reported discomfort, assessed by OHIP-EDENT.
| 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture adaptation accuracy | 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. | At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture retention force | Retention force of the dentures will be evaluated by applying a dynamometer gauge at the following locations: Post dam, Tuberosities and retromolar pads. | 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Technical Complications | Complications will be recorded and assessed as either:
| At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Biological Complications | 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. | At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| OHIP-EDENT Questionnaire. | 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. | 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Patient Satisfaction | Patient satisfaction including aesthetics as evaluated by patient questionnaire including the following questions:
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 | 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture quality assessed via volumetric loss | Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Volumetric loss measured in mm3. | At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture quality assessed via maximum vertical loss. | Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Maximum vertical loss measured in μm. | At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture quality assessed by discolouration (delta E) at a central incisor (#8). | Discolouration (intrinsic or interfacial) measured with spectrophotometer. The colour at a central incisor (#8) and the denture just above #8 will be measured. | At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture quality assessed by occlusion (bite position). | Number of occlusal contacts using articulating paper will be documented. | At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture aesthetics - Appropriateness of tooth shape. | Appropriateness of tooth shape assessed by the following Yes/No question: Appropriate Tooth Shape to match facial aesthetics? | At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture aesthetics - Appropriateness of tooth size. | Appropriateness of tooth size assessed by the following Yes/No question: Appropriate Tooth Size to match facial aesthetics? | At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture aesthetics - Appropriateness of tooth arrangement | Appropriateness of tooth arrangements assessed by the following Yes/No questions:
| At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture aesthetics - Appropriateness of tooth colour / colour match | Appropriateness of tooth colour /colour match assessed by the following Yes/No questions:
| At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture aesthetics - Appropriateness of Denture base | Appropriateness of denture base assessed by the following Yes/No questions:
| At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Denture aesthetics - Lip support | Lip support assessed by the following Yes/No questions:
| At baseline (baseline = final denture insertion performed within 6-months from day 1) |
| Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation. | Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit. | From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months. |
| D009140 |
| Musculoskeletal Diseases |