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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT06370260
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years
2. Patients requiring incisional or excisional biopsy in the gingiva or palate
3. Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the consent form
Exclusion Criteria:
1. Age \<18 years
2. Total number of teeth in the selected sextant \<2
3. Existence of orthodontic appliances
4. Presence or history of oral malignant lesions
5. Existence of viral or other infections of the oral cavity, that could interfere with the primary outcomes of the study
6. Currently undergoing and/or has received radiation therapy to the head or neck
7. Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy
8. History of acute myocardial infarction and/or vascular stroke during the last 6 months
9. Patients with poor glycemic control (HbA1c ≥ 7% within the previous 3 months according to American Diabetes Association (ADA) recommendations), uncontrolled type I or II diabetes mellitus or other systemic diseases known to affect oral wound healing
10. Use of antibiotics in the last 1 month prior to biopsy or conditions requiring antibiotic prophylaxis
11. Use of any antimicrobial mouthwash in the last 1 month before the biopsy
12. Concurrent immunocompromised status and/or use of immunosuppressant medications (e.g. corticosteroids) and steroid inhalers or nasal sprays within the last 1 month prior to enrollment
13. Malnutrition
14. Alcohol abuse and (illicit) drug use disorders
15. Pregnancy or lactation/nursing/breast feeding
16. Known allergy to any of the ingredients of the study products
17. Inability to provide informed consent
18. Participation in another study of an investigational product or device until the primary endpoint is met
19. Other medical condition that, in the opinion of the investigator, may be causing the patient's non-compliance with the clinical investigation plan or confusion in interpreting the data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06370260
Study Brief:
Protocol Section:
NCT06370260