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

Atrophic Maxilla 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05400044
• Other study ID #: 1222
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophic Maxilla
• Atrophy

Intervention

Procedure:
• Three dimensional maxillary bone augmentation
mixing of bone marrow aspirate concentrate with xenograft to show the bone quality and bone gain compared to the xenografts mixed with autografts

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histomorphometric bone analysis	ratio of mineralized tissue to non mineralized tissue	4 months
Secondary	Alveolar ridge vertical bone and horizontal bone gain	Gain measured in millimeters on a cone beam computed tomograpghy	4 months