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68 Participants NeededMy employer runs this trial

3D Printed + Milled Dentures for Toothless Jaw

AS
Overseen ByAda Saltarski
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dentsply Sirona Implants and Consumables
Disqualifiers: Systemic health issues, Pregnancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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).

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have been without all their teeth in both jaws for at least a year and need complete dentures. Participants must be able to understand the study, agree to follow-up visits over 5 years, and sign consent.

Inclusion Criteria

Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years
History of edentulism of at least 1 year
Subject has signed and dated the informed consent form
See 4 more

Exclusion Criteria

Known allergy or hypersensitivity to any of the components
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
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 3D printed or milled complete dentures

6 months
Multiple visits for denture fitting and adjustments

Follow-up

Participants are monitored for denture survival, retention force, and technical complications

5 years
Regular visits at 3 and 6 months, and annually up to 5 years

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two types of full dentures: those made using 3D printing (Lucitone Digital Print) versus those made by milling (Lucitone Digital Fit). The main goal is to see how well each type lasts after one year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Milled denturesExperimental Treatment1 Intervention
Group II: 3D printed denturesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dentsply Sirona Implants and Consumables

Lead Sponsor

Trials
68
Recruited
4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

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