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Biograft-G in Dentistry

Effectiveness and safety of Biograft-G in bone repair of the bucal complex. - EB-1

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000212
Enrollment
Unknown
Registered
2016-03-11
Start date
2010-02-02
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral bone rehabilitation

Interventions

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

Sponsors

Biomaterials Center, University of Havana
Lead Sponsor
Dental Teaching Clinic of Bauta
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Cuba

Contacts

Public ContactMayra Perez Alvarez

Bauta Dental Teaching Clinic

dntimefa@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026