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

Cairo University (CU)

Status: Begins enrollment this month

Conditions: Alveolar Cleft Grafting

Treatments: Other: autogenous bone plug; Other: regular autogenous bone grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT07137975

OMFS3-3-14

Details and patient eligibility

About

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.

Full 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.

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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)

Enrollment: 16 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria:

   • Patients with unilateral alveolar clefts who completed pre-operative expansion.
   • Patients with good oral hygiene.
   • Patients free from any medical condition that might compromise the healing process.
   • Both males and females will be included in trail.
   • Age range from 7 years to 12 years.

2. Exclusion criteria:

   • Unmotivated/uncooperative patients and/or parents.
   • Patients who previously underwent unsuccessful treatment trails.
   • Patients with insufficient ridge expansion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

autogenous bone plug

Active Comparator group

Treatment:

Other: autogenous bone plug

control

Experimental group

Treatment:

Other: regular autogenous bone grafting