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

NCT05400044 | Unknown DMC

• 1 other identifier: 1222
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Atrophic Maxilla

Outcome Measures

Primary Outcomes (1)

• Histomorphometric bone analysis

  ratio of mineralized tissue to non mineralized tissue

  4 months

Secondary Outcomes (1)

• Alveolar ridge vertical bone and horizontal bone gain

  4 months

Study Arms (2)

bone marrow aspirate mixed with xenograft

EXPERIMENTAL

Procedure: Three dimensional maxillary bone augmentation

xenograft mixed with autografts only:

ACTIVE COMPARATOR

Procedure: Three dimensional maxillary bone augmentation

Interventions

Three dimensional maxillary bone augmentation PROCEDURE

mixing of bone marrow aspirate concentrate with xenograft to show the bone quality and bone gain compared to the xenografts mixed with autografts

bone marrow aspirate mixed with xenograft; xenograft mixed with autografts only:

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
• Previous grafting procedures in the edentulous area.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: February 22, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 31, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

EG (1)