Status:
TERMINATED
An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM
Lead Sponsor:
Dentsply International
Conditions:
Mouth, Edentulous
Eligibility:
All Genders
18+ years
Brief Summary
This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate ...
Detailed Description
This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using additive manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (C...
Eligibility Criteria
Inclusion
- Subject is 18 years or older.
- Subject has given written consent to participate in the trial.
- Subject is in good general health.
- Subject requires a new removable full denture for both jaws.
- Subject is completely edentulous in the maxilla and mandible.
- Subject is already wearing a full denture in the maxilla and mandible.
- Subject is willing to undergo dental treatment to receive a new full denture for both jaws.
- Subject confirms availability for treatment and all indicated follow-up visits.
Exclusion
- Subject is younger than 18 years.
- Subject is pregnant.
- Subject has disabilities that do not allow a regular dental treatment.
- Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.
- Subject is currently participating in another study.
- Subject has an allergic history regarding materials used in this trial.
- Subject with xerostomia/ dry-mouth syndrome.
- Lack of compliance is expected.
- Those subjects who cannot provide informed consent for any reason
- Acute stomatitis.
- Status after tumor treatment in head-neck region (removal, radiotherapy).
- Acute cancer.
- Incomplete hard and/or soft tissue in the oral cavity.
- Muscle and/or nerve damage in the head-neck region.
- Insufficient vertical height and/or insufficient mouth opening.
- Resilient hyperplastic mucosa ("flappy ridges").
- Bruxism.
- Insufficient oral hygiene. The existing dentures should have no visible calculus.
- Previously enrolled in the present investigation.
- Involvement in the planning and conduct of the clinical investigation. (applies to all Dentsply Sirona \& Carbon 3D staff, investigational site staff staff and third party vendor).
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04023006
Start Date
August 1 2019
End Date
April 1 2020
Last Update
February 10 2021
Active Locations (1)
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1
Boston University Goldman School of Dental MEdicine
Boston, Massachusetts, United States, 02118