Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial.

Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial. - Clinical effect of cultured periosteal sheet for treating chronic periodontitis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018788

Enrollment

Registered

2015-08-24

Start date

2007-01-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic periodontitis

Interventions

Single arm 1. 30 patients 2. At periodontal surgery after debridement, the coagulated platelet-rich plasma and hydroxyapatite granules was placed into the defect and then cultured periosteal sh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 years or older and 80 years younger persons who obtained written informed consent. 2. Persons satisfied with a standard of biosafety level 1. 3. Free of systemic complications. 4. Completion of periodontal initial treatment. 5. Accept for periodontal surgery. 6. Persons who had one infrabony defect with probing depth: 6mm and more, clinical attachment level:6mm and more. Osseous defect depth estimated to be 4mm and more radiographically.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Clinical Attachment Levelat 12-month postsurgery.	—

Secondary

Measure	Time frame
Radiographic Infrabony Defect Depth at 12-month postsurgery.	—

Countries

Japan

Contacts

Public ContactKazuhiro Okuda

Niigata University Graduate School of Medical and Dental Sciences

okuda@dent.niigata-u.ac.jp0252272870

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026