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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT02153268
Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications:
Sinus augmentation
* Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
* Subjects that have a rehabilitation dentist and rehabilitation program
* Up to dated panoramic X-Ray.
* Subjects who provided written informed consent to participate in the study, able to understand study procedure and agree for follow up procedures
* Healthy conditions of Maxillary Sinuses and Oral Mucosa.
* Sub-antral bone at least 4 mm as measured on CBCT/CT.
* Have a good oral hygiene condition as per investigator discretion.
Bone grafting after removal of cysts from jaws
* Healthy subject.
* Subjects that have a rehabilitation dental treatment.
* Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
* Subjects referred to oral \& maxillofacial Dpt for removal of cysts after diagnosis of the cyst type.
* Healthy bone determined by X-ray.
* Have a good oral hygiene condition.
* Subject that does not participate in other clinical study.
* Subject able to read and understand and sign the informed consent
Exclusion Criteria:
* Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis.
* Subject treated with systemic steroid treatment
* Subjects with known autoimmune diseases, such as: Addison's disease Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome Systemic lupus erythematosus, Type I diabetes.
* Subjects that have Vitiligo and/or known scar healing problems (keloid formation).
* Subjects treated with anticoagulation medication (such as Coumadin, Plavix and other similar medications)
* Subjects treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
* Subjects with a history of Chemotherapy or Radiotherapy treatment
* In case of sinus augmentation - Unhealthy conditions of Maxillary Sinuses.
* Subjects with current active infection or illness
* Subjects participating in another clinical trial 30 days prior to and during the study period
* Pregnant or lactating woman. Pregnancy will be verified by urine test during screening
* Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation
* Subjects with any known allergy for anesthesia
* Positive serology for either HIV, hepatitis B or hepatitis C
* Abnormal clinically significant as per investigator's judgment laboratory test and exams findings
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02153268
Study Brief:
Protocol Section:
NCT02153268