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Patients who undergo mandibular reconstruction using a pre-flexed osseosynthesis reconstruction plate along with free-tissue transfer for reconstruction of a mandibular continuity defect.

Patients who undergo mandibular reconstruction using a 3D-printed reconstruction plate made by selective laser melting (SLM), along with free-tissue transfer for reconstruction of a mandibular continuity defect.

Mandibular reconstruction with free tissue transfer (free-flap bony reconstruction) requires the use of a titanium plate to secure bony segments until bony healing is complete. Plates are made of titanium but can be customised to the anatomical shape of the mandible by two different techniques: flexing (bending) of the plate before surgery, or printing of the plate from titanium alloy powder bed fusion techniques (additive manufacturing, such as selective laser melting).

Mandibular reconstruction with free tissue transfer.

A Goodson, MBBS

M Williams, PhD

M Kittur, MBBS

JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.

JaW PrinT is a 'real-world' prospective observational pilot study, evaluating the clinical effectiveness, usability and economics of two approaches to mandibular reconstruction surgery (using flexed titanium versus printed titanium patient-specific osseosynthesis plates). Patient participants will be recruited prospectively over a minimum period of 18 months (with observation of at least 10 participants in each treatment pathway). The figures are based upon the historical clinical practice of the research site, with both techniques in equal use; choice depending on resources, surgical training requirements and surgeon's clinical preference.

As a purely observational study, treatment choice will be made in the normal clinical manner and will in no way be influenced by the study itself.

Participants will be followed up at their routine outpatient clinics (6 weeks, 6 months and 1 year postoperatively) with prospective outcomes data collection.

Participants will be recruited prospectively as they present as new patient cases to the Maxillofacial and Head \& Neck cancer multidisciplinary team (MDT) clinics. Once a potential patient participant has been given his/her diagnosis and it is confirmed by the principal investigator (PI) that he/she meets the inclusion criteria, clinic staff will provide the potential participant with an invitation letter introducing the study as well as a patient information sheet and consent form (explaining the available options of participating or refraining from the study). Patients will be allowed up to 24 hours to decide whether or not to participate as to avoid any impact/delay on the scheduling of their clinical treatment. The PI will obtain written informed consent from willing participants.

Upon recruitment, provision of informed consent and collection of baseline data, as per standard clinical practice, the patient participant's CT scan data is used to produce a virtual surgical plan for the mandibular resection and fibular free-flap reconstruction. Once the clinically optimal reconstructive surgical plan is established by the surgeon and technician, the choice of surgical approach will be made in the routine clinical manner by the surgeon: Pathway A (pre-flexed customized mandibular reconstruction plate and cutting guides) or to pathway B (SLM customized mandibular reconstruction plate and cutting guides). Both treatment pathways are already part of routine/standard clinical practice at the research site.

The expected/planned patient numbers for this study are based upon the historical workload of the department, typically at 10-20 cases annually. A recruitment period of 18 months with follow-up for 1 year fits within the time constraints of the postgraduate student investigator's PhD timeline.

Jaw Reconstruction With Printed Titanium and Free Tissue Transfer

Dimensional accuracy of the bony reconstruction, as demonstrated by comparing 6 months postoperative CT scan DICOM data with a presurgical digital surgical plan.

The impact of surgical technique (pathway A or B) on the duration of insetting the bony flap into the mandibular continuity defect.

Using 5 point Likert scale ratings of ease of flap preparation, ease of locating the reconstruction plate on the fibula, confidence with technique, ease of mandibular reconstruction, ease of locating the reconstruction plate on the mandible, bony apposition of fibula-fibula and fibula-mandible osteotomies as planned, satisfaction with morphology of reconstructed mandible, confidence with technique overall (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).

List of all required adjustments to the planned reconstructive surgical procedure (e.g. trimming of osteotomies etc.) are recorded.

Incidence of intra/peri/post-operative complications are recorded (e.g. infection, plate exposure, prolonged hospital stay, non-union etc.)

Qualitative Evaluation of changes in dental occlusion by evaluating dental plaster of Paris models (presence or absence of "malocclusion" pre and post-operatively) PLUS assessment/rating of feasibility of dental implant rehabilitation in relation to actual bony reconstruction using a 5 point likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)

Subjective scoring of patient's own perceptions of their quality of life relating to their appearance using the Derriford Appearance Scale

University of Washington v4.0 questionnaire score.

Evaluation of cost differences (if any) between patient groups

Liverpool oral rehabilitation questionnaire scores.

stereophotogrammetry to assess facial symmetry.

University of South Wales

Symptoms and General Pathology

Cysts

Mandibular Neoplasms

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
Jaw Reconstruction With Printed Titanium and Free Tissue Transfer	NCT03905005	Neoplasm, Oral Osteoradionecro... Mandibular Dise... Jaw Cancer Jaw Diseases Surgery	Mandibular reco...	18 Years -	University of South Wales
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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