Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial.
Phase 2
- Conditions
- Chronic periodontitis
- Registration Number
- JPRN-UMIN000018788
- Lead Sponsor
- iigata University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. Persons who do not accept written informed consent. 2. Persons not satisfied with a standard of biosafety level 1. 3. Persons who had severe systemic complications. 4. Un-completion of periodontal initial treatment. 5. Persons who were unable to accept for periodontal surgery. 6. Persons who had not one infrabony defect with probing depth: 6mm and more, clinical attachment level: 6mm and more. and osseous defect depth estimated to be 4mm and more radiographically. 7. Persons who had the allergy due to medication. 8. Persons who are judged to be unqualified for this study subjects by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Attachment Levelat 12-month postsurgery.
- Secondary Outcome Measures
Name Time Method Radiographic Infrabony Defect Depth at 12-month postsurgery.