Treatment for maxillary cysts

Phase 1

Recruiting

Conditions: Cysts and benign tumors of the jaw
Maxillary Diseases
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Maxillary Neoplasms
Jaw Cysts
Neoplasms
Bone Cysts
Cysts

Registration Number: RPCEC00000274

Lead Sponsor: aval Hospital of Acapulco of the Mexican Navy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>Therapeutic efficacy (healing of the lesion assessed by physical examination). Measurement time: baseline, at 3, 30, 60, 180 and 360 days.

Secondary Outcome Measures