Evaluation of the intra-lesional application of a inductive bioactive formulation for the treatment of cysts and tumors of the facial mass: Clinical Trial Phase I-ll - TXMAXILAR

aval Hospital of Acapulco of the Mexican Navy0 个研究点目标入组 30 人开始时间: 2018年5月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•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.

•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.

发起方

aval Hospital of Acapulco of the Mexican Navy