An interventional study of Lucitone Digital Print and Lucitone Digital Fit in Edentulous Mouth and Edentulous Jaw, sponsored by Dentsply Sirona Implants and Consumables. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Dentsply Sirona Implants and Consumables (part of Dentsply Sirona) · Not applicable, Interventional, and Supportive care
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).
122 studies on the registry are indexed under Jaw, Edentulous; 20 are open to participants now.
This study's planned enrollment of 68 is above the median of 24 across 99 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →Dentsply Sirona Implants and Consumables is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Compared within Jaw, Edentulous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mouth, Edentulous. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PDI Completely edentulous classification (Class 4)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3D printed denture bases and 3D printed denture teeth.
Device: Lucitone Digital Print
Milled denture bases and denture teeth.
Device: Lucitone Digital Fit
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
Consisting of the following parts: * Lucitone Digital Fit Denture Discs. * Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.
Denture survival rate
Restorations still in function after 1 year.
Time frame: One year after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture survival rate
Restorations still in function after 3 and 6 months, and 2, 3, 4 and 5 years.
Time frame: 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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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: * Major complications (requiring laboratory intervention to correct - fracture, lab reline, etc.). * Minor complications (requiring chairside adjustment - sore spots, occlusal discrepancies, etc.).
Time frame: 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.
Time frame: 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.
Time frame: 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: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?
Time frame: 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?
Time frame: 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: * 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?
Time frame: 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: * 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?
Time frame: 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: * Appropriate tooth to gingival display? * Appropriate physical characterisation (contours) of denture base that appears natural and pleasing?
Time frame: 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: * 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?
Time frame: 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.
Time frame: From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Oct 2028, 25 months after the start.
Of 66 interventional studies with no phase under Jaw, Edentulous, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's planned 25 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dentsply Sirona Implants and Consumables →