Edentulous Jaw, Edentulous Mouth
Conditions
Brief summary
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).
Interventions
DEVICELucitone Digital Print
Consisting of the following parts: * Lucitone Digital Print 3D Denture Base. * Lucitone Digital Interpenetrating Polymer Network (IPN) 3D Premium Tooth. * Lucitone Digital Print Denture System Accessories
DEVICELucitone Digital Fit
Consisting of the following parts: * Lucitone Digital Fit Denture Discs. * Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult aged 18 years or above at time of informed consent. * Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation. * Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years. * Subject has signed and dated the informed consent form. * Subjects in need of complete dentures in maxilla and mandible. * Prosthodontic Diagnostic Index (PDI) Completely edentulous classification (Class 1-3). * History of edentulism of at least 1 year.
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) * Presence of severely atrophied ridge. * Presence of severe ridge undercuts. * Clinically severe Xerostomia. * Absence of hard or soft tissue pathology that precludes denture therapy. * Maxillofacial defects. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Denture survival rate | One year after baseline (baseline = final denture insertion performed within 6-months from day 1) | Restorations still in function after 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Denture survival rate | 3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1) | Restorations still in function after 3 and 6 months, and 2, 3, 4 and 5 years. |
| Denture success | 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) | 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). |
| Denture adaptation accuracy | At baseline (baseline = final denture insertion performed within 6-months from day 1) | 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. |
| Denture retention force | 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) | Retention force of the dentures will be evaluated by applying a dynamometer gauge at the following locations: Post dam, Tuberosities and retromolar pads. |
| Technical Complications | 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) | 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.). |
| Biological Complications | 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) | 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. |
| OHIP-EDENT Questionnaire. | 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) | 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 | 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 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 |
| Denture quality assessed via volumetric loss | 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) | Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Volumetric loss measured in mm3. |
| Denture quality assessed via maximum vertical loss. | 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) | Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Maximum vertical loss measured in μm. |
| Denture quality assessed by discolouration (delta E) at a central incisor (#8). | 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) | Discolouration (intrinsic or interfacial) measured with spectrophotometer. The colour at a central incisor (#8) and the denture just above #8 will be measured. |
| Denture quality assessed by occlusion (bite position). | 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) | Number of occlusal contacts using articulating paper will be documented. |
| Denture aesthetics - Appropriateness of tooth shape. | At baseline (baseline = final denture insertion performed within 6-months from day 1) | Appropriateness of tooth shape assessed by the following Yes/No question: Appropriate Tooth Shape to match facial aesthetics? |
| Denture aesthetics - Appropriateness of tooth size. | At baseline (baseline = final denture insertion performed within 6-months from day 1) | Appropriateness of tooth size assessed by the following Yes/No question: Appropriate Tooth Size to match facial aesthetics? |
| Denture aesthetics - Appropriateness of tooth arrangement | At baseline (baseline = final denture insertion performed within 6-months from day 1) | 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? |
| Denture aesthetics - Appropriateness of tooth colour / colour match | At baseline (baseline = final denture insertion performed within 6-months from day 1) | 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? |
| Denture aesthetics - Appropriateness of Denture base | At baseline (baseline = final denture insertion performed within 6-months from day 1) | 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? |
| Denture aesthetics - Lip support | At baseline (baseline = final denture insertion performed within 6-months from day 1) | 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? |
| Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation. | From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months. | Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit. |
Countries
United States
Contacts
CONTACTAda Saltarski
CONTACTUlrika Bonander
Outcome results
None listed