Safety and efficacy of allogeneic bone as a bone filling material for sinus floor augmentation

JRCT ID: jRCTs072210054

Registered date:27/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atrophic maxillary alveolar bone
• Date of first enrollment: 27/08/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Use of allograft chips for maxillary sinus augmentation

Outcome(s)

• Primary Outcome: augmentation volume

Secondary Outcome

histological findings of allograft
maxillary sinus membrane thickness
safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients who have a preference to receive a dental implant treatment for missing tooth in the maxillary posterior region.
2. Patients whose alveolar bone volume are insufficient for ideal implant placement, and are required the sinus floor augmentation for the dental implant placement.
3. Patients who can personally provide written consent at their own free will after being receiving a thorough explanation of the study and fully understanding their participation in the study.

Exclude criteria

1. Patients with problem in judgement.
2. Patients with drug hypersensitivity such as allergy.
3. Women who are or may be pregnant or lactating women.
4. Patients who are participating in another clinical study.
5. Patients are immunocompromised with severe diabetes or severe liver or renal dysfunction.
6. Patients with severe peptic ulcer or cardiovascular or respiratory diseases and disorders,
7. Smokers
8. Patients receiving therapies with anti-resorption drugs such as bisphosphonate which affect bone metabolism .
9. Partients who are judged to be inappropriate to participate the study by the principal or cooperative doctors.

Related Information

• Primary Sponsor: Ohba Seigo