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

NCT07137975 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

  • Alveolar Cleft Grafting

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137975 on ClinicalTrials.gov