3D Printed Dentures for Toothless Jaw

Overseen By Raphael de Souza, DDS,MSc,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Severe systemic disease, Cognitive impairment, Intraoral pathologies, Implant failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether 3D printed dentures offer better comfort and satisfaction than traditional dentures for seniors without teeth. Participants will receive two types of dentures: one set made with advanced 3D printing technology and the other using standard methods. The goal is to determine which type provides a better fit and improves quality of life. Seniors who have been toothless for a while, need new dentures, and have had implants in their lower jaw (mandibular implant overdentures) may be suitable for this study. Participants will wear each pair for three months and share their experiences to help improve future denture designs. As an unphased trial, this study allows participants to contribute to innovative dental solutions that could enhance comfort and quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that 3D printed dentures are safe for edentulous patients?

Research has shown that 3D-printed implant overdentures are generally safe and well-tolerated. A 20-year study on these dentures in older adults reported positive long-term results, confirming their safety. Another study found that 3D-printed titanium implants, used in similar dental procedures, effectively and safely rebuild the jaw.

These findings suggest that 3D printing for dentures does not introduce new safety concerns compared to traditional methods. Users have reported good results, and no major negative effects have been noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D printed mandibular implant overdentures because they offer a cutting-edge method to improve denture fit and aesthetics compared to traditional approaches. This technique uses digital scans and 3D printing to create dentures that are tailored precisely to a patient's unique anatomy, potentially leading to better comfort and functionality. Additionally, the ability to conduct a virtual try-in allows patients to visualize and tweak their smile before finalizing the dentures, offering a personalized experience. This digital pathway could streamline the denture-making process and reduce time-consuming adjustments, which is a significant advancement over conventional methods.

What evidence suggests that 3D printed dentures are effective for edentulous patients?

This trial will compare 3D-printed mandibular implant overdentures with traditional mandibular implant overdentures. Research has shown that 3D-printed implant overdentures can improve patients' quality of life compared to traditional dentures. Studies indicate that these dentures fit better and are more comfortable. They are also quicker and cheaper to produce, making them a promising option for seniors who have lost teeth. Using computer technology, 3D-printed dentures can be customized to fit each person, potentially leading to higher satisfaction. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for edentulous seniors aged 60 or older who have had two implants in the front of their lower jaw and want new upper and lower dentures. They must understand English or French, be able to consent, live independently, not have had teeth extracted in the last year, and not suffer from severe diseases or cognitive impairments.

Inclusion Criteria

I have had two specific dental implants in my lower jaw for over 3 months.

I want new upper dentures and lower implants with studs.

I have not had a tooth removed in the last year.

Exclusion Criteria

I do not have a severe illness that frequently requires hospitalization.

I experience jaw pain or dysfunction.

I have no serious mouth diseases that could affect how a denture fits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Digital Denture

Participants receive a digitally fabricated mandibular overdenture using CAD and 3D printing, worn for 3 months.

3 months

4 visits (in-person)

Treatment - Traditional Denture

Participants receive a traditionally fabricated mandibular overdenture, worn for 3 months.

3 months

4 visits (in-person)

Follow-up

Participants are monitored for maintenance requirements and adverse effects, including stained and broken dentures.

12 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mandibular Implant Overdentures

Trial Overview

The study compares patient satisfaction with two types of mandibular overdentures: one made using digital design and 3D printing technology versus a traditional method. Participants will try both sets for three months each to see which they prefer based on comfort and quality of life.

How Is the Trial Designed?

Group I: 3D printed mandibular implant overdenture Experimental Treatment 1 Intervention

First appointment: The first visit will consist of scanning the patients' existing upper complete denture and lower mandibular implant overdenture by using a desktop scanner. In the lab, the .stl files will be 3D printed using a DLP 3D printer. Second clinical appointment: the interim printed dentures will be adjusted with wax for the desired lip support and VD. Secondary impressions will be taken to refine fit. Maxillary and mandibular interim printed dentures will be scanned separately and together with an intraoral scanner. Patient's face will also be scanned by a face scanner. 2nd lab session: .stl files will be superimposed for the digital pathway. Teeth and denture bases will be designed virtually. Dentures bases will be manufactured by a DLP 3D printer with Dentca Resin. Dentures will receive Dentsply Portrait 3D teeth. Dentures will be finished and polished, and sandblasted in the attachment sockets. 4th appointment: denture delivery.

Group II: traditional mandibular implant overdenture Active Control 1 Intervention

The first visit will be the same. For the conventional pathway, the 2nd lab session will consist of pouring the impressions (type 4 stone), mounting the casts in arcon semi-adjustable articulator, removing the printed teeth, and replacing it with wax rim and acrylic tooth setup (Dentsply Portrait - same shape, size and shade used for 3D printed dentures). A 3rd appointment will be used for wax try-in for the conventional pathway. For the digital pathway, participants will have a chance to appraise their smile on a computer screen (virtual try-in, done remotely) and request modifications. Denture bases will be manufactured with conventional heat-polymerized resins, and participants will return for a 4th appointment for delivery, including chairside pick-up of attachments (GC Reline resin). Two short-term adjustments will be scheduled 24-72 h and 7 days after delivery, and then weekly until the dentures are comfortable.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

ITI International Team for Implantology, Switzerland

Collaborator

Trials

24

Recruited

1,000+

Citations

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study protocol for a mixed-methods cross-over RCT - PMC

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3D Printed Dentures for Toothless Jaw · Info for Participants

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This study indicated that the prudent application of fully customized subperiosteal jaw implants is a dependable alternative for the dental rehabilitation of ...