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

JRCT ID: jRCTs072240085

Registered date:11/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Jaw Deformity
• Date of first enrollment: 11/12/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Inserting Octacalcium Phosphate-Collagen Composite into the Bone Gap Created during Le Fort I Osteotomy.

Outcome(s)

Primary Outcome

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.

• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 70age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kei-ichiro Miura
• Secondary Sponsor: Yamada Tomohiro