Bone deficiencies in the alveolar ridge
Conditions
Interventions
Use DBBM as bone filler for 1-stage and 2-stage lateral sinus floor augmentation in the edentulous posterior maxilla. Implant is placed on the same day for the 1-stage, 6 months later for the 2-stage
Sponsors
Baek Kyung-won
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be eligible to participate in the study if all of the following conditions exist: 1. Partial edentulism of posterior maxilla, in need of up to 3 implants 2. Adults between 18 and 80 years of age at time of consent 3. Signed Informed consent 4. Ability to participate to the study for its whole duration (12-month) 5. For 1-stage: Residual alveolar bone height > 3 mm and 5.5 mm or less 6. For 2-stage: Residual alveolar bone height 3 mm or less
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in the study if any of the following conditions exist: 1. All smokers, including smoking alternatives 2. Heavy drinker (> 60 g of alcohol per day as a mean) 3. Uncontrolled metabolic disorders e.g., diabetes mellitus, osteomalacia, thyroid disorder, severe renal or hepatic disorder 4. Prolonged corticosteroid therapy 5. Immunological impairment diseases 6. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years 7. General contraindications for dental and/or surgical treatment (including anticoagulants) 8. Disease or condition affecting bone metabolism 9. Women of child-bearing age, not using a highly effective method of birth control 10. Pregnancy or breast feeding 11. Previous and concurrent medication affecting sinus healing in general (e.g., topical steroids, large doses of anti-inflammatory drugs) 12. Maxillary sinus pathologies 13. Acute or chronic oral infection or uncontrolled periodontal disease 14. Crestal bone defects at the implantation site, which require additional bone augmentation around the neck of the implant 15. Allergy to collagen 16. Participation in an investigational device or drug clinical trial within the last six months 17. Parafunction (bruxism, clenching) requiring daily night guard
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant success defined by: - 1-stage: Implant success (Inflammation/Infection, Pain on chewing, Mobility, Patient Satisfaction at the implant level, Vertical bone loss) 1 month after the final prosthesis, Total score = 5 - 2-stage: Implant Insertion Torque Value (ITV) at the time of implantation (by manual or pneumatic torque wrench), ITV 12 Ncm or more | — |
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed