Cysts and benign tumors of the jaw
Conditions
Interventions
Experimental group: Bioactive Formula (patent US 9089580 B1). Intra-cystic application of the solution called bioactive formula. Initially the fluid is drained from the cyst. The dose depends on the a
Liquid drainage between 4 and 8mL: Apply one milliliter of bioactive formula
Liquid drainage greater than 8mL: Apply two milliliters of bioactive formula. The procedure is ambulatory and is performed percutaneously. It is repeated at 7, 30, 60 and/or 90 days, if in these perio
Drainage
Ambulatory Surgical Procedures
Sponsors
Naval Hospital of Acapulco of the Mexican Navy
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Medical School of the University of Colima, Mexico
Eligibility
Sex/Gender
All
Age
9 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer patients over 18 years of age who sign informed consent. 2. Patients between 9 and 17 years old, who agree to receive treatment and whose parents or guardians authorize and sign an informed consent (both parents or guardians). 3. Patients with clinical, radiographic and histopathological diagnosis of any of the following pathologies of benign histology: dentigerous cysts, odontogenic keratocystic tumors, ameloblastomas, ossifying fibroblasts, fibrous dysplasia, Gorham-Stout syndrome, other benign histology lesions of the jaws selected at the discretion of the specialist. 4. Patients with diseases described in previous point and with recurrence to previous treatments.
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Decompensated systemic disease . 4. Creatinine 1.25 times the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 5. Blood leucocytes less than 3000 cells / microliter or platelet count less than 100,000 / microliter. 6. Blood hemoglobin less than 10 g / deciliter. 7. Increase in the last month of diastolic blood pressure to 110 mmHg or more. 8. Hematuria or proteinuria greater than 300 milligrams/day. 9. Women who are lactating, pregnant or of childbearing age and sexually active without contraception: salpingoclasm, intrauterine device or hormonal contraceptives. This condition must be maintained for at least 6 months after the last application of the inductive bioactive formulation. 10. Alcoholism and/or drug addiction. 11. Known liver disease with twice the increase in liver function tests (Aspartate aminotransferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin). 12. Presence of Cancer. 13. Other pathologies at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Bone necrosis or tissues adjacent to the lesion, cystic progression, bone or muscle changes not compatible with a normal anatomy, muscle weakness in the jaw, xerostomia, dysphagia, mucositis or stomatitis, nausea, skin atrophy, ecchymosis, changes in skin pigmentation, fibrosis , alterations in the state of consciousness, pain in the area of application and in injury, neurological events, alterations in the liver enzymes or blood count, jaw fracture, spillage of the jaw joint, cardiovascular events. Measurement time: baseline, at 3, 7, 30, 60, 90, 180 and 360 days. Therapeutic efficacy (healing of the lesion assessed by physical examination). Measurement time: baseline, at 3, 30, 60, 180 and 360 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone formation in the lesion (computerized axial tomography of the affected area). Measurement time: baseline, at 60 and 360 days. | — |
Countries
México
Contacts
Public ContactIvan Delgado-Enciso
Cancerology State Institute, Colima State Health Service
Outcome results
None listed