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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT05961566
Eligibility Criteria:
Inclusion Criteria:
* Demographic
1. Age: 18-65 years old
2. Gender: Any
3. Race: Any
4. Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years
* Medical History
1. Physically and mentally healthy with no contraindications for periodontal surgery
2. American Society of Anesthesiologists: ASA-I or ASA-II
* Dental history
1. Periodontally healthy
2. No history of surgical interventions in the palate
3. No history of cleft lip/palate
4. No history of orthodontic treatment involving the palate (palatal expansion).
* Other
1. Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate.
2. Patients who are able and willing to provide informed consent
3. Patients who are able and willing to follow study appointments
Exclusion Criteria:
* i. Medical History
1. Smokers or users of nicotine replacement products
2. Patients with a contraindication, e.g., allergy, for any of the medications or materials used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen, acetaminophen, Glycolon ® sutures, collagen sponge matrix)
3. Patients with diabetes (glycemic level \> 110mg/l and HbA1c \> 6.5%)
4. Drug or alcohol abuse history
5. Pregnancy, lactation.
6. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
7. Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc.
8. Medications affecting periodontal status in the previous 6 months
9. Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc.
* Dental
1. Patients with any history of palatal surgery
2. Patients with inadequate donor site anatomy
3. Poor oral hygiene
1. Full-mouth plaque ≥ 20%
2. Bleeding scores \> 10%
4. Untreated periodontitis
1. Pocket depths \> 3mm with BOP
2. No active periodontal disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05961566
Study Brief:
Protocol Section:
NCT05961566