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Effect of blood derivative on dead bone formation in jaws caused by certain medicines.

Effect of Leucocyte platelet rich fibrin on healing of medicine induced osteonecrosis of jaw- pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010174
Enrollment
15
Registered
2017-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: C00-D49- Neoplasms Health Condition 2: null- Patients who have developed medicine related osteonecrosis of jaw (MRONJ) lesions due to antiresorptive drugs like Bisphophonates

Interventions

Intervention1: Platelet Rich fibrin: Platelet rich fibrin is derived from patients own blood by centrifuging 10 ml whole blood in controlled laboratory environment. The PRF formed in each individual

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients who are on, or who have had, treatment with antiresorptives or antiangiogenic agents i.e. Zoledronate, Alodronate, Pamidronate, Ibandronate, Denosumab, Sunitinib, Sorafenib, Bevacizumab and who have necrosis of jaw bone (ONJ) 2) Patients with ONJ sites that had failed to heal for 8 weeks or longer despite continuous treatment with antimicrobial drugs 3) Age > 18 years

Exclusion criteria

Exclusion criteria: 1. Patients who have been given radiotherapy to head neck region 2. Patients who have neoplastic involvement of the jaw. 3. Patients in whom MRONJ extends till lower border of mandible / sinus floor / zygoma requiring major ostectomies for debridement of necrosed bone

Design outcomes

Primary

MeasureTime frame
Complete resolution of MRONJ lesionTimepoint: 1 month 4 Months

Secondary

MeasureTime frame
1. Down grading of MRONJ lesion 2. Symptoms of MRONJ pain, swelling, dischargeTimepoint: 1 month 4 months

Countries

India

Contacts

Public ContactDr Sandeep Gurav

Tata Memorial Hospital

kdholam@hotmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026