Back to resultsAssessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial
Primary Purpose
Atrophic Maxilla
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Three dimensional maxillary bone augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Maxilla
Eligibility Criteria
Inclusion Criteria:
Patients are free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous anterior or posterior maxilla with deficient alveolar ridge that is less than 5 mm measured from the crest of the alveolar ridge to the nasal or maxillary sinus and less than 4mm in buccolingual width.
- The minimum number of missing teeth in the alveolar ridge is two adjacent teeth.
Exclusion Criteria:
Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area.
Sites / Locations
- Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bone marrow aspirate mixed with xenograft
xenograft mixed with autografts only:
Arm Description
Outcomes
Primary Outcome Measures
Histomorphometric bone analysis
ratio of mineralized tissue to non mineralized tissue
Secondary Outcome Measures
Alveolar ridge vertical bone and horizontal bone gain
Gain measured in millimeters on a cone beam computed tomograpghy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400044
Brief Title
Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial
Official Title
Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Assessment of bone quality and quantity for three dimensional bone augmentation for maxilla using titanium meshes loaded with bone marrow aspirate mixed with xenograft versus xenograft mixed with autografts only
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Maxilla
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bone marrow aspirate mixed with xenograft
Arm Type
Experimental
Arm Title
xenograft mixed with autografts only:
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Three dimensional maxillary bone augmentation
Intervention Description
mixing of bone marrow aspirate concentrate with xenograft to show the bone quality and bone gain compared to the xenografts mixed with autografts
Primary Outcome Measure Information:
Title
Histomorphometric bone analysis
Description
ratio of mineralized tissue to non mineralized tissue
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Alveolar ridge vertical bone and horizontal bone gain
Description
Gain measured in millimeters on a cone beam computed tomograpghy
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients are free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
Edentulous anterior or posterior maxilla with deficient alveolar ridge that is less than 5 mm measured from the crest of the alveolar ridge to the nasal or maxillary sinus and less than 4mm in buccolingual width.
The minimum number of missing teeth in the alveolar ridge is two adjacent teeth.
Exclusion Criteria:
Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
Previous grafting procedures in the edentulous area.
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial
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