Treatment for maxillary cysts

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

TXMAXILAR

Scientific title:

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

Acronym of Scientific Title:

TXMAXILAR

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

ESTERIPHARMA Foundation for Ethics, Education and Research for Cancer of the State Institute of Cancerology of Colima, A.C.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Antonio

Last name:

Reynaldos del Pozo

Medical Specialty :

Maxillofacial surgeon

Affiliation:

Naval Hospital of Acapulco of the Mexican Navy

Postal address:

Avenue Costera Miguel Aleman 1, Icacos

City:

Acapulco

Country:

Mexico

Zip Code:

39860

Telephone:

+52-7444847053

Email address:

reynaldosmaxilo04@yahoo.com.mx [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

México

Clinical sites:

Hospital medical center "Clínica Union", Villa de Alvarez Colima, Principal Investigator: Juan Paz Garcia, MD, Maxillofacial Surgeon

Research ethics committees:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima), Octoberber 16, 2015 (Central Ethics Committee)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

29/10/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Cysts and benign tumors of the jaw

Health condition(s) code:

Jaw Cysts

Maxillary Neoplasms

Bone Cysts

Cysts

Maxillary Diseases

Jaw Diseases

Musculoskeletal Diseases

Stomatognathic Diseases

Neoplasms

Intervention(s):

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 amount of fluid that was drained from the cyst. Liquid drainage less than 4mL: Apply half a milliliter of bioactive formula; 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 periods of time the cystic lesion persists and fluid is drained.

Intervention code:

Drainage

Injections, Intralesional

Administration, Cutaneous

Ambulatory Surgical Procedures

Intervention keyword:

Bioactive Formula

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

Bone formation in the lesion (computerized axial tomography of the affected area). Measurement time: baseline, at 60 and 360 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

9 years

Maximum age:

None

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.

Type of population:

Children/Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1-2

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivan

Last Name:

Delgado-Enciso

Specialty:

General Medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email :

ivancoliman@hotmail.com [2]

ivan_delgado_enciso@ucol.mx [3]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Juan

Last Name:

Paz-Garcia

Specialty:

Maxillofacial Surgery

Affiliation:

Hospital medical center "Clinica Union"

Postal Address:

Avenue Enrique Corona Morfin 90, Colonia La Frontera

City:

Villa de Alvarez, Colima

Country:

Mexico

Zip Code:

28950

Telephone:

+52 3123195722

Email :

dr_juanpaz@hotmail.com [4]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000274

Date of Registration in Primary Registry:

30/05/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [5]