Diseases and Abnormalities at or Before Birth

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Mandibular Neoplasms

Mandibular Injuries

Maxillofacial Injuries

Facies

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Autologous, anatomically shaped bone graft

EB-CMF

Brian R Gastman, MD

Rebeka Silva, DMD, FACD

Beverly Doyle

Erin Locke, BSN, RN

EpiBone-Craniomaxillofacial (EB-CMF) is an autologous, anatomically shaped bone graft created specifically for the patient's defect, using the patients own adipose-derived mesenchymal stem cells. This first in human trial is designed specifically to assess the safety of EB-CMF clinically. Although secondary measures of graft efficacy are being assessed, the primary focus will be on Adverse Events stemming from graft implantation.

Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction

An Open-Label, First-in-Human, Single Intervention Study for Evaluation of EpiBone-CMF Engineered Living Bone Graft for Mandibular Ramus Reconstruction

Yearly observation of bone regeneration by high-resolution CT scan until the subject withdraws from the study or termination of the study.

To assess the safety of EB-CMF for up to 12 months post surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction.

To assess the efficacy of the EpiBone-CMF graft for up to 12 months post-surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction. Bone regeneration as assessed by high-resolution CT scans for up to 12 months post-surgery.

To assess the changes in quality of life for up to 12 months post-surgery in patients as measured by the Glasgow Benefit Inventory.

To assess the changes in quality of life for up to 12 months post-surgery in patients as measured by SF-12.

Epibone, Inc.

Jaw Neoplasms

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Jaw Diseases

Mandibular Diseases

Stomatognathic Diseases

Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate

Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins were carried out around the teeth to be included in the resection. The osteotomy lines were marked using a long shank surgical tapered fissure bur. The osteotomies completed and the resected segment was removed.

Mandibular marginal resection and reconstruction

a 2.3 mm reconstruction bone plate was then fit in place and fixed to both the proximal and distal segments

mandibular osteosynthesis a 2.3mm reconstruction bone plate

Mohamed K Allam, Ass prof

The purpose of this study is to evaluate the reliability of using mandibular osteosynthesis a 2.3mm reconstruction bone plate in the maintenance of the space, contour, and mandibular bone preservation during marginal mandibular resection.

This prospective study included 16 patients (n=16) suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection.

Patient history included personal data (name, age, sex, and occupation), date of lesion discovery, mode of growth (rapid or slow), and symptoms (e.g. pain and/or ipsilateral paresthesia of the lower lip).

Clinical examination included the site and extent of mandibular bony expansion and covering soft tissues (normal, ulcerated from indentation of opposing teeth, or scarred due to previous incisional biopsy).

Radiographical examination involved orthopantomography (OPG) and axial and coronal computed tomography (CT) scans to assess the lesion extensions.

All patients are operated under general anesthesia which was induced by intravenous access. Intubation is routinely performed in nasoendotracheal fashion.

Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins are carried out around the teeth to be included in the resection.

The plastic template is adapted to the buccal cortex of the mandible to aid in the final adaptation of a 2.3 mm reconstruction bone plate (Antonhib, Germany). The osteotomy lines are marked using a long shank surgical tapered fissure bur. a 2.3 mm reconstruction bone plate is then fit in place and fixed to both the proximal and distal segments then removed. The osteotomies completed and the resected segment is removed, and the reconstruction plate is then replaced by the aid of screw holes in both the proximal and distal segments. The intraoral wound is carefully closed in double layers using a combination of interrupted and horizontal mattress resorbable 3/0 sutures.

post operative follow up clinically regarding soft tissue healing, pain, infection, and plate exposure or plate fracture. Radiographically, Panoramic radiographs are taken immediately and axial and coronal computed tomography at six months post-operatively.

Mandibular Reconstruction Bone Plate

Reliability of a 2.3mm Mandibular Reconstruction Bone Plate in Mandibular Bone Preservation

The degree of pain is determined during the follow up periods according the scale of Kerkmanov and Nordenram , Mild: require one tablet of analgesics three times/ day, Moderate: require two tablets of analgesics three times/ day, Severe: require injective analgesics.

The wounds were inspected accurately post-operatively for detecting the proper healing using inflammation score scale, 0 no inflammation,1-3 mild inflammation, 4-7,moderate inflammation, 8-10 sever inflammation

using Infection score scale , mild infection which responds to antibiotics, only without the need for incision and drainage, moderate infection which needs for incision and drainage and severe infection which needs for incision and drainage in addition to hardware removal.

Tanta University

Associate professor

Cysts

ten patients with mandibular benign lesions which were treated with bone lid technique to enucleate the lesion using piezo-electric device to allow removal of buccal bone cortex with preservation of it to have access to lesion then reposition of bone lid in its place

ten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion

group I ten patients with mandibular lesion will be undergo excision of lesion using bone lid technique with piezo-electric device then reposition of buccal bone cortex

bone lid technique

group II ten patients with mandibular lesion will be undergo excision of lesion using surgical bur to remove buccal cortex to get access to lesion

standard technique

mona s sheta

Twenty patients with benign mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

The patients will be evaluated clinically to evaluate healing and radiographically using cone beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six months later

Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid technique performed using a piezoelectric device versus the traditional technique in patients requiring excision of the mandibular bony lesions

Materials \& Methods: Twenty patients with mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.

Surgical procedure: A full thickness flap will be elevated in both groups to achieve access to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond the actual extension of lesion in radiograph using piezoelectric device to secure a latter repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in saline. After excision of the lesion, the bony lid will be repositioned to its original position and fixed to the bone with an absorbable suture.

In group II the bone will be removed buccally using surgical bur then the lesion is removed. Finally, the flap will be sutured in both groups.

Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of infection, inflammation, necrosis, or bone exposure each week for one month then monthly for six months.

Radiographically, (CBCT) scan six months later to evaluate Healing and integration of the repositioned bone lid, any signs of recurrence in the case of cysts, and filling of the bone defect bone healing and volume of the defect.

All selected cases of both groups b were went for CBCT scan using fixed exposure parameters (Kv, mA) and the same field of view prior surgery and 6 months post-surgical using the same axial slicing to evaluate the following

1. Cyst area in coronal view for posterior region and sagittal view for anterior region
2. Evaluating lesion location by making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion using (Coronal view posterior, sagittal anterior).

3- recurrence of lesion , integration of buccal cortex 4- bone density

Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions

Lecturer of Oral and Maxillofacial Surgery

using visual analogue scale:0 represent no pain and 10 represents the highest level of pain

adequate means closed or inadequate means open wound

1 means mild,2 means moderate or3 means sever infection

making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.

CBCT to measure density (D1\> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield

0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation

presence of radiolucency around of buccal cortex or not

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	NCT03678467	Mandible Tumor Mandibular Inju... Mandible; Defor...	EB-CMF	18 Years - 65 Years	Epibone, Inc.
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	NCT03678467	Mandible Tumor Mandibular Inju... Mandible; Defor...	EB-CMF	18 Years - 65 Years	Epibone, Inc.
Evaluation of EpiBone-CMF for Mandibular Ramus Reconstruction	NCT03678467	Mandible Tumor Mandibular Inju... Mandible; Defor...	EB-CMF	18 Years - 65 Years	Epibone, Inc.
Mandibular Reconstruction Bone Plate	NCT06099431	Mandible Tumor	Mandibular marg... mandibular oste...	12 Years - 50 Years	Tanta University
Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions	NCT05987930	Mandible Cyst Mandible Tumor Mandibular Dise...	bone lid techni... standard techni...	6 Years -	Tanta University
Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions	NCT05987930	Mandible Cyst Mandible Tumor Mandibular Dise...	bone lid techni... standard techni...	6 Years -	Tanta University

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