Biograft-G in Dentistry

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000212
• Date of registration: 11/03/2016
• Prospective Registration: No
• Primary sponsor: Biomaterials Center, University of Havana
• 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
• Affiliation: Bauta Dental Teaching Clinic

• Name: Jose Angel Delgado Garcia-Menocal
• 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

Secondary Sponsor(s)

Dental Teaching Clinic of Bauta