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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

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05400044
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
10.3
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Three dimensional maxillary bone augmentation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 22, 2022
Anticipated Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Histomorphometric bone analysis [4 months]

    ratio of mineralized tissue to non mineralized tissue

Secondary Outcome Measures

  1. Alveolar ridge vertical bone and horizontal bone gain [4 months]

    Gain measured in millimeters on a cone beam computed tomograpghy

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
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:

  • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.

  • Previous grafting procedures in the edentulous area.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mostafa, Mr, Cairo University
ClinicalTrials.gov Identifier:
NCT05400044
Other Study ID Numbers:
  • 1222
First Posted:
Jun 1, 2022
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrophy

Study Results

No Results Posted as of Jun 1, 2022