CClinicalTrials.gg
Status unknownNCT05400044Updated Jun 1, 2022

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

An interventional study of Three dimensional maxillary bone augmentation in Atrophic Maxilla, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2022, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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

02

Conditions studied

  • Atrophic Maxilla

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03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 603 interventional studies indexed under Atrophy.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    bone marrow aspirate mixed with xenograft

    Procedure: Three dimensional maxillary bone augmentation

  • Active comparator
    xenograft mixed with autografts only:

    Procedure: Three dimensional maxillary bone augmentation

Interventions

  • ProcedureThree 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

06

What researchers measure

Primary outcomes

  1. Histomorphometric bone analysis

    ratio of mineralized tissue to non mineralized tissue

    Time frame: 4 months

Secondary outcomes

  1. Alveolar ridge vertical bone and horizontal bone gain

    Gain measured in millimeters on a cone beam computed tomograpghy

    Time frame: 4 months

07

Study locations

1 site
  • Cairo university
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05400044
Lead sponsor
Cairo University
Responsible party
Ahmed Mostafa (Mr, Cairo University) — Principal investigator
First posted
Jun 1, 2022
Start date
Feb 22, 2022
Primary completion
Dec 22, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jun 1, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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