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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT06622759
Eligibility Criteria:
Inclusion Criteria:
1. Generally healthy adult patients.
2. 18 years or older.
3. Need for replacement of single implant in the upper aesthetic zone (second premolar to second premolar)
4. Ridge width (bucco-lingual) no greater than 6 mm at its narrowest point.
5. Minimum 2mm of attached gingiva.
6. Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations.
7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
Exclusion Criteria:
1. Poor oral hygiene (FMPS \< 20%, FMBS \< 15%) and poor motivation
2. Heavy smokers (\>10 cigarettes per day)
3. Need for bone augmentation
4. Untreated periodontitis
5. General contraindications for dental and/or surgical treatment
6. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
7. Women of child bearing age, not using a standard accepted method for contraception
8. Pregnancy or breast feeding
9. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs
10. Disease affecting connective tissue metabolism (e.g. collagenases)
11. Allergy to collagen
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06622759
Study Brief:
Protocol Section:
NCT06622759