JPRN-jRCTs011180002
Recruiting
Phase 2
Evaluation of Usefulness of Bisphosphonate for diffuse sclerosing osteomyelitis of the jaw - Evaluation of Usefulness of Bisphosphonate for diffuse sclerosing osteomyelitis of the jaw
Kitagawa Yoshimasa0 sites13 target enrollmentNovember 16, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diffuse Sclerosing Osteomyelitis of the jaw
- Sponsor
- Kitagawa Yoshimasa
- Enrollment
- 13
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients suspected diffuse sclerosing osteomyelitis of jaw clinically in Hokkaido university hospital. The final diagnosis of DSO is determined as follows in the conference by oral surgery specialist.
- •1Recurrent pain and swelling of the mandible, with no sign of infection with microorganisms.
- •2CT images of DSO patients showed an intermingled sclerotic and lytic pattern in the cortex and medulla.
- •3Antimicrobial treatment has not proved to be effective.
- •4No history of irradiation to the maxillofacial area and received long\-term bisphosphonate therapy.
- •Inclusion Criteria
- •1over 15 years old
- •2written informed consent
- •3Performance Status 0 or 1
Exclusion Criteria
- •1\)Patients diagnosed Anti\-resorptive agents\-related ONJ
- •2\)Patients who received other bisphosphonate.
- •3\)Children of 15 years or under.
- •4\)pregnancy, nursing woman or possibly pregnant woman.
- •5\)Patients with severe renal disorders(BUN:\=\<1\.5 upper limit of normal,Cr:\=\<1\.5 upper limit of normal)
- •6\)patients who are contraindications for Voltaren
- •7\)patient that physician determined inappropriate.
Outcomes
Primary Outcomes
Not specified
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