Status:
COMPLETED
Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane
Lead Sponsor:
GBR Academy
Conditions:
Surgical Procedure, Unspecified
Soft Tissue Infections
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The presence of alveolar ridge deficiencies is considered major limitation to achieve an implant-prosthetic restoration with high aesthetics and stability over time. Guided Bone Regeneration (GBR) can...
Detailed Description
The rationale of the study is based on the fact that manual and intraoperative modeling of an osteosynthesis mesh is an employee operator and even in the case of very experienced operators it is alway...
Eligibility Criteria
Inclusion
- Adult patients, over the age of 18, in good general health.
- Patients with partial edentulism of the maxilla or mandible, with a 2mm minimum to a 12mm maximum vertical bone defect, which requires a three-dimensional bone regeneration intervention in order to have a fixed implant supported rehabilitation.
- Obtaining informed consent for experimental treatment and processing the personal data.
- Exclusion Criteria:
- Poor oral hygiene,
- Untreated periodontal disease
- Smoking habit\> 10 cigarettes / day;
- Abuse of alcohol or drugs
- Pregnancy
- Patients with odontostomatological infections and / or systemic infections in progress;
- Patient with uncontrolled diabetes mellitus or other metabolic diseases;
- Patients with severe changes in liver and kidney function.
- Patients with confirmed uncontrolled autoimmune disorders.
- Patients subjected radiation therapy in the head or neck region in the last 5 years.
- Patients undergoing immunosuppressive and / or immunocompromised therapy
Exclusion
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04286334
Start Date
December 1 2017
End Date
August 1 2022
Last Update
August 3 2022
Active Locations (1)
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1
School of Dentistry - University of Bologna
Bologna, Italy, 40126