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A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneration

A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneration - A prospective, multi-center, single-arm study of OCP/Col

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018192
Enrollment
60
Registered
2015-07-07
Start date
2015-07-07
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

bone defect

Interventions

Implantation of OCP/Collagen as a bone sbstitute material with sinus floor augmentation, socket preservation, cleft palate operation, or cystectomy.

Sponsors

TOYOBO CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient that socket presarvetion or sinus floor lift operation are adaptation before dental implant treatment. Patient with a cyst less than 3 cm. Patient with a cleft palate less than 2 cm in width.

Exclusion criteria

Exclusion criteria: Patient suffering severe hepatopathy, renal disorders, and heart disease who would affect safety evaluation of this trial. Patient who has an allergy drug. Patient who has a bone metabolism disease like osteoporosis or has a medication of bisphosphonate. Patient who has a medication of steroid or immunosuppressant (The local administration is excluded). Patient who receives an anticoagulant therapy. Patient who is pregnant, possibly pregnant, nursing or considering pregnancy. Patient who has an uncontroled diabetes. Smoker, but the patient who was able to confirm intention of the smoking cessation before clinical trial participation is excluded. Patient who participated other clinical trial program within 3 months prior to the study entry Others, patient who is unfit for the study as determined by the principal investigator or sub-investigators

Design outcomes

Primary

MeasureTime frame
Sinus floor augmentation:Initial success degree of dental implant treatment, The insertion torque of a dental implant, Biopsy Socket preservation:The insertion torque of a dental implant, Biopsy Cystectomy:CT value Cleft palate operation:CT value

Secondary

MeasureTime frame
The implant stability quotient (ISQ) values, Radiographycal analysis.

Countries

Japan

Contacts

Public ContactTadashi Kawai

Tohoku University Hospital Oral and Maxillofacial Surgery

ta-shi@dent.tohoku.ac.jp022-717-8350

Outcome results

None listed

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