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Clinical Trials/RPCEC00000274
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.

Registry
who.int
Start Date
May 30, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
aval Hospital of Acapulco of the Mexican Navy

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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