Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT03997604
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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 sift 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/Affordable staff and third party vendor).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03997604
Study Brief:
Protocol Section:
NCT03997604