Biograft-G in Dentistry

Phase 4

• Conditions: Oral bone rehabilitation; Mouth Rehabilitation

• Registration Number: RPCEC00000212
• Lead Sponsor: Biomaterials Center, University of Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>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.<br>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.<br>