Comparative study of the safety and efficacy of the bio-degradable membranes for guided bone regeneration

JRCT ID: jRCTs072200063

Registered date:09/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alveolar bone atrophy
• Date of first enrollment: 03/02/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Bone biopsy is performed for category 3 subjects

Outcome(s)

• Primary Outcome: Efficacy: Amount of bone formation evaluated by CT analysis
• Secondary Outcome: Safety and Efficacy evaluated by ISQ value of dental implants and histrogical evalusation with bone biopsy

Key inclusion & exclusion criteria

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

Include criteria

1. Patients who require alveolar ridge augmentation with GBR for oral rehabilitation using dental implants
2. 20 plus and under 90 years old
3. Patients who make written informed consent.

Exclude criteria

1. Patients who have sever blood diseases
2. Patients who have calcium metabolic diseases, or immune system abnormalities.
3. Patients who are difficult to be followed up
4. .Patients who are restricted to comply the requirements of this study.
5. Smokers
6. Patients who needs the legal representative.
7. Partients who are judged to be inappropriate to participate the study by the principal or cooperative doctors.

Related Information

• Primary Sponsor: Seigo Ohba
• Source(s) of Monetary Support: GC Corporation
• Secondary ID(s): Nil known