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

26 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mandibular Implant Overdentures for toothless jaws?

Research shows that 3D-printed implant overdentures can improve the quality of life for patients compared to traditional methods, and long-term studies indicate that mandibular implant-supported overdentures are effective for elderly patients over 20 years, suggesting they are a reliable option for toothless jaws. ^{1 2 3 4 5}

Is it safe to use 3D-printed dentures for toothless jaws?

Research shows that 3D-printed dentures, including those supported by implants, have been evaluated for safety in various studies. A 20-year study on implant-supported overdentures in elderly patients reported positive long-term outcomes, suggesting they are generally safe for use. ^{1 2 6 7 8}

What makes 3D printed dentures for toothless jaw unique compared to other treatments?

3D printed dentures for a toothless jaw are unique because they use advanced 3D printing technology to create dentures that fit more accurately and comfortably compared to traditional methods. This approach can improve the quality of life for patients by providing a better fit and potentially faster production time. ^{1 5 8 9 10}

What is the purpose of this trial?

CAD/CAM (computer-aided design and computer-aided manufacturing) can be a game-changer for better access to care by edentulous patients. Digital overdentures offer potential for more satisfied patients due to better fit and can be provided faster/with lower costs. Providing digital overdentures has potential to enhance access to oral healthcare by the elderly, given the expected benefits (better quality, simpler, faster and more affordable than those obtained traditionally). However, evidence from randomized trials is crucial to verify the relevance of those benefits, especially from the patient perspective, and to confirm those benefits. This trial also serves as an opportunity to improve CAD software and materials, since it will identify technical challenges specific to the provision of digital overdentures. This randomized cross-over trial aims to reveal whether implant-retained mandibular overdentures (IMO) produced by CAD and 3D printing are more satisfactory to edentulous seniors than those fabricated using traditional methods. The investigators will recruit 26 edentulous participants (any sex/gender) amongst previous patients at McGill University, based on the following eligibility criteria: complete edentulism, elderly (age ≥60 years, according to the WHO), need for new maxillary and mandibular complete dentures, ability to complete questionnaires, and previous treatment with two implants in the anterior mandible. Each participant will receive two pairs of dentures, as per the McGill Consensus on Implant Overdentures (i.e., a mandibular overdenture opposed by a maxillary complete denture: (i) one by digital rendering of the mouth, virtual prosthetic design and 3D printing; (ii) a control pair, by traditional clinical and laboratory methods. Each pair will be worn for 3 months according to a random sequence (total follow-up: 6 months after the delivery of the first pair of dentures). Both overdentures will be retained by 2 Novaloc abutments and medium retention matrices. Outcomes will include patient satisfaction ratings and oral health-related quality of life. The investigators will evaluate other patient-reported outcomes, as well as clinician-assessed quality and cost. Outcome assessment will occur at baseline, then at three months after participants have worn each pair of dentures. Following the cross-over, participants will keep their preferred denture pair and return after 12 months to evaluate maintenance requirements, including stained and broken dentures.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of implant overdentures fabricated using 3D-printing technology versus conventional fabrication techniques: a randomized clinical trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Mandibular implant-supported overdentures in (frail) elderly: A prospective study with 20-year follow-up. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Retrospective Comparison of Postinsertion Maintenances Between Conventional and 3D Printed Complete Dentures Fabricated in a Predoctoral Clinic. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Additively manufactured CAD-CAM complete dentures with intraoral scanning and cast digitization: A controlled clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Complete digital workflow for prosthesis prototype fabrication with double digital scanning: A retrospective study with 45 edentulous jaws. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

Accuracy of a chairside, fused deposition modeling three-dimensional-printed, single tooth surgical guide for implant placement: A randomized controlled clinical trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Precision of Custom Edentulous Trays Fabricated with 3D Printing Technologies. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The Effect of Build Orientation on the Dimensional Accuracy of 3D-Printed Mandibular Complete Dentures Manufactured with a Multijet 3D Printer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Primary Exploration of the Clinical Application of 3D-Printed Complete Dentures. [2023]