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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Atrophic Maxilla

Intervention / Treatment
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* Procedure: Three dimensional maxillary bone augmentation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bone marrow aspirate mixed with xenograft<br> | Procedure: Three dimensional maxillary bone augmentation<br>* mixing of bone marrow aspirate concentrate with xenograft to show the bone quality and bone gain compared to the xenografts mixed with autografts<br>|
| Active Comparator: xenograft mixed with autografts only:<br> | Procedure: Three dimensional maxillary bone augmentation<br>* mixing of bone marrow aspirate concentrate with xenograft to show the bone quality and bone gain compared to the xenografts mixed with autografts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometric bone analysis | ratio of mineralized tissue to non mineralized tissue | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar ridge vertical bone and horizontal bone gain | Gain measured in millimeters on a cone beam computed tomograpghy | 4 months |