Clinical Outcomes of 3D Printed and Milled Complete Dentures (NCT07586774) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Outcomes of 3D Printed and Milled Complete Dentures
United States68 participantsStarted 2026-05-30
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 patholog…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Denture survival rate
Timeframe: One year after baseline (baseline = final denture insertion performed within 6-months from day 1)