Effect of blood derivative on dead bone formation in jaws caused by certain medicines.
Not Applicable
Completed
- Conditions
- Health Condition 1: C00-D49- NeoplasmsHealth Condition 2: null- Patients who have developed medicine related osteonecrosis of jaw (MRONJ) lesions due to antiresorptive drugs like Bisphophonates
- Registration Number
- CTRI/2017/10/010174
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete resolution of MRONJ lesionTimepoint: 1 month <br/ ><br>4 Months
- Secondary Outcome Measures
Name Time Method 1. Down grading of MRONJ lesion <br/ ><br>2. Symptoms of MRONJ pain, swelling, dischargeTimepoint: 1 month <br/ ><br>4 months