Tissue-Engineered Osteogenic Material for maxillomandibular bone defect

JRCT ID: jRCTb041190076

Registered date:06/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: maxillomandibular bone defect
• Date of first enrollment: 10/05/2016
• Target sample size: 29
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Transplantation of bone marrow-derived mesenchymal cells, platelet rich plasma, thrombin, calcium chloride and beta-TCP

Outcome(s)

• Primary Outcome: Rate of procedure sites with successful bone regeneration

Secondary Outcome

1) Regenerated bone height
2) Percentage of the regenerated bone height over the height of the initial defect
3) CT value
4) Rate of successful implant placement
5) Time from transplantation to implant placement
6) Survival rate and time of implant
7) Tooth mobility
8) Masticatory force
9) Histological assessment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who require bone regeneration satisfying all of the inclusion criteria below:
more than 20-year-old patients who have a maxillomandibular bone defect that lies over 1/3 of the maxillomandibular area with remaining bone of up to 10 mm in height due to maxillofacial injury or tumor/cyst removal (Patients who had surgical tumor removal in maxillomandibular region must not have relapse/metastasis for 5 year of observation period after the procedure)
2. Patients who have received plaque control instructions by a dentist or a dental hygienist and are in a good management of it
3. Patients who are willing and able to give signed consent

Exclude criteria

1. Patients with bone defect as a result of periodontitis
2. Patients for whom surgical procedure is prohibited e.g, severe heart disease, congenital coagulation factor deficiency, leukemia, dialysis, end-stage malignant tumor
3. Patients with or with a history of infection
4. Patients with diabetes that is not well-controlled
5. Patients taking bisphosphonates for more than 3 months or denosumab for more than 6 months before the consent
6. Patients with or with a history of malignant tumor
7. Patients taking steroids or immunosuppressive drugs who cannot stop such medication for 4 weeks after trial intervention
8. Patients in a serious condition of certain diseases
9. Patients with difficulty in bone marrow aspiration
10. Patients from whom a sufficient amount of blood cannot be taken for PRP preparation
11. Patients with contraindications to local anesthetics
12. Patients with a history of hypersensitivity to antibiotics, antifungals, thrombin products, or bovine blood-derived products
13. Patients taking hemocoagulase products, tranexamic acid products, or aprotinin products
14. Female patients who are pregnant, suspected to be pregnant, breastfeeding, or those who do not agree to practice contraception
15. Any other patients whom the trial investigator deemed ineligible to this study

Related Information

• Primary Sponsor: Okabe Kazuto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development