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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02117856
Eligibility Criteria:
Inclusion Criteria:
* functional in English or accompanied by a responsible adult who can provide translation services
* able to consent to, and participate in, the treatment provided
* available for the duration of the study
* edentulous and with at least six month's experience with conventional complete dentures
* currently wearing conventional complete dentures that are esthetically satisfactory to the patient and technically acceptable in the judgment of the study prosthodontist(s)
* medically/psychologically suitable for implant surgery in the judgment of the study dentists
Exclusion Criteria:
* insufficient alveolar bone height for implant(s) (\< 10 mm)
* history of head and neck radiation
* systemic or neurological disease, including: American Society of Anesthesiologists (ASA) Class 3 with recently diagnosed severe systemic disease, e.g. recent (within 6 months) myocardial infarction or stroke; risks associated with bacteraemia, e.g. immune compromise, steroids, in-dwelling catheters, stents, prosthetic heart valves, etc.; Type 1 diabetes, pituitary and adrenal insufficiency, and untreated hypothyroidism; chronic granulomatous disease, e.g. tuberculosis and sarcoidosis; bone disease, e.g. histiocytosis X, Paget's disease, fibrous dysplasia; history of congenital or acquired uncontrolled bleeding, e.g. coumadin
* previous oral implant treatment
* need for additional pre-prosthetic surgery
* need for new complete dentures
* medically/psychologically unsuitable for surgery in the opinion of the study dentists
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02117856
Study Brief:
Protocol Section:
NCT02117856