Biograft-G in Dentistry

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:

EB-1

Scientific title:

Effectiveness and safety of Biograft-G in bone repair of the bucal complex.

Acronym of Scientific Title:

EB-1

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Biomaterials Center, University of Havana Public Health Ministry of Cuba

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:

Mayra

Midle name:

de la Caridad

Last name:

Perez Alvarez

Medical Specialty :

Specialist of first grade in dentistry

Affiliation:

Dental Teaching Clinic of Bauta

Postal address:

Ave 251, No. 13204, Bauta

City:

Artemisa

Country:

Cuba

Zip Code:

32600

Telephone:

+53-047374197

+53-047372623

+53-047372891

Email address:

dntimefa@infomed.sld.cu

mayra@biomat.uh.cu

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:

Cuba

Clinical sites:

Artemisa, Dental Teaching Clinic "Raúl Gonzalez Sanchez", Lubenia García Rodríguez, MD. Specialist General Integral Stomatology

Pinar del Rio, "Leon Cuervo Rubio" Hospital, Hermes Somonte Davila, MD. Specialist Maxillofacial Surgery

Matanzas, "Faustino Pérez" Hospital, Jorge Hernandez, MD. Specialist Maxillofacial Surgery

La Habana, National Centre of Stomatology (CENAEST), Maria Estrella Marin, MD. Specialist General Integral Stomatology

Research ethics committees:

Artemisa , Bauta Dental Teaching Clinic , September, 4-2009

Artemisa, Dental Teaching Clinic "Raúl Gonzalez Sánchez", September, 17-2009

Pinar del Rio, ""Leon Cuervo Rubio" Hospital, November, 11-2010

Matanzas, "Faustino Perez" Hospital, September, 18-2012

La Habana, National Centre of Stomatology (CENAEST), January,17-2012

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

02/02/2010

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:

Oral bone rehabilitation

Health condition(s) code:

Mouth Rehabilitation

Intervention(s):

Experimental group: The surgical technique is performed following the steps of conventional oral surgery using as cavity filling the biomaterial Biograf-G.

Intervention code:

Surgery, Oral

Intervention keyword:

Biograft-G

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):

Clinic appearance (Success: The appearance of soft tissue in the operated site similar to nearby normal tissue; Failure: The appearance of the soft tissue at the site edema or erythema intervened.). Measuring time: 7 days, 1 month, 3 months and 6 months after treatment. Radiographic appearance (Success: The density in the bone cavity covers 50% or more of the defect; Failure: The density in the bone cavity covers less than 50% of the defect). Measuring time: 7 days, 1 month, 3 months and 6 months after treatment.

Key secondary outcomes:

Infection (Success: Absence of pus and signs of inflammation in the treated site; Failure: presence of pus and signs of inflammation in the treated site). Measuring time: 7 days, 1 month, 3 months and 6 months after treatment. Exfoliation (Success: No output of pellets placed in default; Failure: Output of pellets placed in default). Measuring time: 7 days, 1 month, 3 months and 6 months after treatment. Hypersensitivity (Success: No reaction involving life-threatening, hospitalization, disability or persistent disability; Failure: Presence of the mentioned reactions). Measuring time: 7 days, 1 month, 3 months and 6 months after treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

75 years

Inclusion criteria:

1- Patients who meet the established diagnostic criteria. 2- Age range between 18 and 75 years, both sexes, Cuban citizen without distinction of race. 3- Outpatient whose health allows them to perform a normal physical activity without restrictions or light work. 4- Patients that can be treated surgically. 5- Patients give their written consent for participation to be included 6- Patients with periodontal infra bony origin involved bone defects whose teeth have no mobility than Grade 2 according to Miller’s classification

Exclusion criteria:

1- Diabetic patients decompensated or difficult to control. 2- Immunocompromised or patients under immunosuppressive therapy. 3- Mentally retarded. 4- Patients with malignancies diagnosed, from any location. 5- Patients who are pregnant. 6- Patients with conditions of smoking and alcoholism. 7- Patients with difficulties in tracking for residing in distant places. 8- Patients who refuse to be included in the investigation. 9- Patients with horizontal bone loss or periodontal defects supraóseos origin

Type of population:

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:

4

Target sample size:

recruitment during 5 years since February 2010 (121 patientes)

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:

Mayra

Middle Name:

de la Caridad

Last Name:

Perez Alvarez

Specialty:

Specialist of first grade in dentistry

Affiliation:

Bauta Dental Teaching Clinic

Postal Address:

Ave 251, No. 13204, Bauta

City:

Artemisa

Country:

Cuba

Zip Code:

32600

Telephone:

+53(047)374197

Email :

dntimefa@infomed.sld.cu

mayra@biomat.uh.cu

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:

Jose

Middle Name:

Angel

Last Name:

Delgado Garcia-Menocal

Specialty:

PhD. Chemistry Sciences

Affiliation:

Biomaterials Center, University of Havana, Cuba

Postal Address:

University Avenue, Revolution Square

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53 78700594

Email :

jadelgado@biomat.uh.cu

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:

RPCEC00000212

Date of Registration in Primary Registry:

11/03/2016

Record Verification Date:

2016/03/11

Next update date:

2017/03/11

Link to the spanish version:

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Biograft-G in Dentistry

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