Clinical Outcomes of 3D Printed and Milled Complete Dentures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDentsply Sirona Implants and Consumables
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lucitone Digital Print
DeviceConsisting 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
Lucitone Digital Fit
DeviceConsisting of the following parts: * Lucitone Digital Fit Denture Discs. * Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: 3D printed denturesExperimental treatment 1 intervention
Group B: Milled denturesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov