Effectiveness and Safety of DBBM in Maxillary Sinus Augmentation for Implants

JRCT ID: jRCT2032230721

Registered date:20/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bone deficiencies in the alveolar ridge
• Date of first enrollment: 10/05/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 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 after the bone augumentation.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old

Include 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
3. Signed Informed consent
4. Ability to participate to the study for its whole duration (12-month or 18-month based on 1-stage or 2-stage, respectively)
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

Exclude 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. Periodontal defects at the implantation site
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

Related Information

• Primary Sponsor: Baek Kyung-won