NCT07137975

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

-The aim of this study is to describe an auxiliary surgical techniques in alveolar cleft reconstruction and evaluate volume of the bone. Research question: Does the use of patient specific autogenous plug yield better 3D volume than conventional autogenous graft. Statement of the problem: Cleft patients need a precise treatment regimen, which makes the treatment challenging. Multidisciplinary approach is required and collaboration of multiple specialties is needed; OMFS, orthodontists, plastic surgeons, speech therapist and pedodontists. One of the most crucial steps in treatment of cleft patients is the repair of the alveolar defect to achieve stability of the arch, provide room for canine and lateral incisor to erupt, maintain periodontal health of adjacent teeth, restore continuity of piriform rim, support the ala of the nose to allow for better facial appearance, closure of oronasal fistula to decrease chance URT infections and allow for better hygiene and speech., It is essential to understand and evaluate the geometry and size of the defect, to avoid improper grafting of the defect, enhance the evaluation of the alveolar defect preoperatively, and the graft integration postoperatively and to allow precise repair of the alveolar defect. (Watted et al., 2020) (Stolarz et al.,2022) Each alveolar cleft has a unique shape in mesio-distally, antro-posteriorly, which creates a challenge to fill the defect in all dimensions. The precise assessment of the cleft geometry can be determined by computed tomography (CT), or cone- beam CT (CBCT) which allows simultaneous alveolar cleft assessment, planning and volume measurement. 4 Rationale for conducting the research: 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. (Kesztyűs et al., 2022)

Conditions

• Alveolar Cleft Grafting

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-08-22
• Last updated: 2026-02-03

Locations

1 site across 1 country: Egypt