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ACTIVE NOT RECRUITING
NCT07137975
NA

Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation. Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure. To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis.

Official title: Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction: A Randomized Clinical Trail

Key Details

Gender

All

Age Range

7 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-08-30

Completion Date

2026-09-30

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

OTHER

autogenous bone plug

Preoperative assessment of the alveolar defect began with intraoral examination to check a proper transverse relationship between the maxillary segments and the presence of a normal upper arch form. After the decision on alveolar bone grafting, Radiologic data from the cleft area will be required. Standard protocol is to take a high resolution CT scan of the patient's skull or at least the whole maxilla. Using the DICOM data acquired from the cleft area the bony defect will be segmented with specific software, in our daily routine blender for dental is used. The same program could be used to design the rough shape of the nasoalveolar graft, and this image could be exported in STL (standard tessellation language) format. and once the desired form is aquired, the final step is to construct a mold. For this purpose, the open-source software Blender (Blender Foundation, Amsterdam, and The Netherlands) will be used. After preoperative planning, the designed mold will be printed using polyam

OTHER

regular autogenous bone grafting

Gold standard grafting of alveolar cleft

Locations (1)

Cairo University

Cairo, Egypt