Study on the safety and osteogenic ability of octacalcium phosphate/collagen complex for jaw deformity surgery

Study on the safety and effectiveness of octacalcium phosphate/collagen complex for jaw deformity surgery (Le Fort I osteotomy) and bone regeneration ability

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072240085

Enrollment

Registered

2024-12-11

Start date

2025-02-17

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

Jaw Deformity oral and maxillofacian surgery

Interventions

Inserting Octacalcium Phosphate-Collagen Composite into the Bone Gap Created during Le Fort I Osteotomy.

Octacalcium phosphate collagen composite

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with jaw deformities and scheduled for Le Fort I osteotomy at the Department of Oral and Maxillofacial Surgery, Nagasaki University Hospital, between the jRCT publication date and March 31, 2028. 2. Patients aged 18 to 70 at the time of surgery 3. Patients who have received a thorough explanation of the study, fully understand it, and have provided written consent of their own free will to participate.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1. Patients with severe liver or kidney dysfunction or heart disease. 2. Patients with a drug allergy. 3. Patients with bone metabolic diseases such as osteoporosis. 4. Patients undergoing antithrombotic therapy. 5. Patients with a history of malignancy within the past 5 years or currently having a malignancy. 6. Pregnant women, women wishing to become pregnant during the study period, and breastfeeding women. 7. Patients participating in another clinical trial or who have participated in another clinical trial and received investigational drugs within 3 months prior to the consent date. 8. Patients with medically uncontrolled diabetes. 9. Smokers. 10. Other patients deemed inappropriate by the principal investigator or co-investigator.

Design outcomes

Primary

Measure	Time frame
Safety Evaluation Items [Subjective Symptoms and Objective Findings] Subjective symptoms and objective findings will be investigated through clinical examination and interviews with the study participants to confirm the presence or absence of adverse events. [Malfunctions] The presence or absence of malfunctions in the medical device under investigation will be confirmed through clinical examination and interviews with the study participants.	—

Measure

Time frame

Safety Evaluation Items [Subjective Symptoms and Objective Findings] Subjective symptoms and objective findings will be investigated through clinical examination and interviews with the study participants to confirm the presence or absence of adverse events. [Malfunctions] The presence or absence of malfunctions in the medical device under investigation will be confirmed through clinical examination and interviews with the study participants.

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Secondary

Measure	Time frame
Evaluating the Efficacy of Octacalcium Phosphate-Collagen Composite in Patients with Jaw Deformities Undergoing Le Fort I Osteotomy (Radiological and Histological Assessment of New Bone Formation.	—

Contacts

Public ContactTomohiro Yamada

Nagasaki University Hospital

t-yamada@nagasaki-u.ac.jp+81-95-819-7697

Outcome results

None listed

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