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

Not Applicable

• Conditions: Atrophic Maxilla
• Interventions: Procedure: Three dimensional maxillary bone augmentation

• Registration Number: NCT05400044
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-22
• Status Verified: 2022-05
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-01
• Last Update Posted: 2022-06-01
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bone marrow aspirate mixed with xenograft	Three dimensional maxillary bone augmentation	-
xenograft mixed with autografts only:	Three dimensional maxillary bone augmentation	-

Primary Outcome Measures

Name	Time	Method
Histomorphometric bone analysis	4 months	ratio of mineralized tissue to non mineralized tissue

Secondary Outcome Measures

Name	Time	Method
Alveolar ridge vertical bone and horizontal bone gain	4 months	Gain measured in millimeters on a cone beam computed tomograpghy

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt