An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM

Stopped early

Conditions studied: Mouth, Edentulous

In brief

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 new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture

Key facts

Study ID

NCT04023006

Run by

Dentsply International

People needed

10

Starts

2019-08-01

Expected to finish

2020-04-01

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Boston University Goldman School of Dental MEdicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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