Wounds and Injuries

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Musculoskeletal Diseases

Mouth and Tooth Diseases

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Osteoradionecrosis

Mandibular Diseases

Jaw Diseases

Mouth Neoplasms

Radiation Injuries

Stomatognathic Diseases

Head and Neck Neoplasms

Mouth Diseases

Oral Cancer

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

Digestive System Diseases

Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Deglutition Disorders

Communication Disorders

Tongue Neoplasms

Neurobehavioral Manifestations

Neurologic Manifestations

Neurodevelopmental Disorders

Mental Disorders

Psychotic Disorders

Tongue Diseases

Quality of Life

Lip and Oral Cavity Cancer

Tongue Cancer

Speech-language guidance for speech enhancement and on food management in terms of consistency, volumes, utensils and temperature, beyond the care for safe and efficient swallowing.

Speech-language guidance

Use of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month.

Speech therapy exercises for swallowing

Use of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month.

Speech therapy exercises for speech

Sady S da Costa, PHD

This study aims to verify the impact of four speech therapy sessions on the Quality of Life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing.

The hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on Quality of Life related to speech and swallowing.

Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy

Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial

To measure the changes in Quality of Life related to swallowing it was used the questionnaire Dysphagia Handicap Index (DHI)

To measure the changes in Quality of Life related to speech it was used the questionnaire Speech Handicap Index (SHI)

To measure the changes in Dysphagia classification it was used the Fiberoptic Endoscopic Evaluation of Swallowing, exam that evaluate the functionability of swallow. These exams were presented to three judges (speech therapists) that in agreement classified the degree of dysphagia

To measure the changes in Speech Intelligibility it was used speech recordings that were analysed by three judges (speech therapists) that in agreement classified the degree of speech intelligibility

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
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy	NCT04126226	Tongue Cancer Jaw Cancer Oral Cancer Intelligibility...	Speech-language... Speech therapy ... Speech therapy ...	18 Years -	Hospital de Clinicas de Porto Alegre
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy	NCT04126226	Tongue Cancer Jaw Cancer Oral Cancer Intelligibility...	Speech-language... Speech therapy ... Speech therapy ...	18 Years -	Hospital de Clinicas de Porto Alegre

Spots Global Cancer Trial Database for jaw cancer

Every month we try and update this database with for jaw cancer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for jaw cancer

Every month we try and update this database with for jaw cancer cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for jaw cancer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.