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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrophic Maxilla
• Intervention / Treatment: Procedure: Three dimensional maxillary bone augmentation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bone marrow aspirate mixed with xenograft	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
Active Comparator: xenograft mixed with autografts only:	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Anticipated): December 22, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 1222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No