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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00991432
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide written informed consent
2. ≥ 18 years
3. Scheduled for dental implant into anterior maxillary alveolar ridge
4. Negative urine pregnancy test for patients of child bearing potential and agreement not to become pregnant for at least 12 months after surgery
5. Able to comply with all study-related procedures, including exercising good oral hygiene
6. A prosthodontic treatment plan has been drafted.
Exclusion Criteria:
1. Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
2. Known hypersensitivity to titanium
3. Operative site is in the area of a resected or extant tumor
4. Any active malignancy or current treatment for a malignancy
5. Active infection at operative site
6. History of prior exposure to rhBMP-2/ACS
7. Received and failed a previous alveolar ridge augmentation procedure
8. Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans
9. Significant untreated periodontal disease (\> Grade III), caries, or chronic inflammation of the oral cavity at operative site
10. Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.
11. Insulin-dependent diabetic, or has known glycated hemoglobin (HgbA1c) levels \>6.5 %
12. History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin
13. Patients who are lactating
14. History of metabolic bone disease, excluding idiopathic osteoporosis
15. History of autoimmune disease (e.g., documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g., human immunodeficiency virus or acquired immunodeficiency syndrome)
16. History of immune deficiency due to other treatments (e.g., radiation therapy, chemotherapy, steroid therapy)
17. History of adverse reaction to prior exposure to silicone or injectable collagen
18. Treatment with an investigational therapy within 1 month before the surgical procedure or plans to be treated with an investigational therapy during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00991432
Study Brief:
Protocol Section:
NCT00991432