RPCEC00000274
Recruiting
Phase 1
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 sites30 target enrollmentMay 30, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cysts and benign tumors of the jaw
- Sponsor
- aval Hospital of Acapulco of the Mexican Navy
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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