Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
RPCEC |
Last refreshed on:
|
1 April 2024 |
Main ID: |
RPCEC00000212 |
Date of registration:
|
11/03/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Biograft-G in Dentistry
|
Scientific title:
|
Effectiveness and safety of Biograft-G in bone repair of the bucal complex. - EB-1 |
Date of first enrolment:
|
02/02/2010 |
Target sample size:
|
recruitment during 5 years since February 2010 (121 patientes) |
Recruitment status: |
Complete |
URL:
|
https://rpcec.sld.cu/en/trials/RPCEC00000212-En |
Study type:
|
Interventional |
Study design:
|
Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
|
Phase:
|
4
|
|
Countries of recruitment
|
Cuba
| | | | | | | |
Contacts
|
Name:
|
Mayra de la Caridad
Perez Alvarez |
Address:
|
Ave 251, No. 13204, Bauta
32600
Artemisa
Cuba |
Telephone:
|
|
Email:
|
dntimefa@infomed.sld.cu |
Affiliation:
|
Bauta Dental Teaching Clinic |
|
Name:
|
Jose Angel
Delgado Garcia-Menocal |
Address:
|
University Avenue, Revolution Square
10400
Havana
Cuba |
Telephone:
|
jadelgado@biomat.uh.cu |
Email:
|
|
Affiliation:
|
Biomaterials Center, University of Havana, Cuba |
| |
Key inclusion & exclusion criteria
|
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
Age minimum:
18 years
Age maximum:
75 years
Gender:
Male/Female
|
Health Condition(s) or Problem(s) studied
|
Oral bone rehabilitation
|
Mouth Rehabilitation
|
Intervention(s)
|
Surgery, Oral
|
Biograft-G
|
Experimental group: The surgical technique is performed following the steps of conventional oral surgery using as cavity filling the biomaterial Biograf-G.
|
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.
|
Secondary Outcome(s)
|
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.
|
Secondary ID(s)
|
Not applicable
|
Source(s) of Monetary Support
|
Biomaterials Center, University of Havana
Public Health Ministry of Cuba
|
Ethics review
|
Status:
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|