Medical Devices for Maxillofacial Trauma and Craniofacial Deformities

Module details

Title

Medical Devices for Maxillofacial Trauma and Craniofacial Deformities

Type

Specialist

Module code

SPE420

Credits

20

Requirement

Compulsory

Aim of this module

This module will enable trainees to gain the knowledge and understanding that  will be applied as they develop their specialist practice. They will continue to learn and gain new work based skills to enable them to competently perform a range of treatments, interact with patients, and demonstrate safe, patient centred practice. Trainees will be expected to build on the competence gained during rotational training developing technical expertise in planning, interpreting and communicating the design and manufacture of dental and medical devices and surgical plans. The module aims to integrate the manufacturing and clinical aspects of reconstructive science as part of a multidisciplinary team approach to treatment and a leadership role in the management of patients requiring prosthetic rehabilitation. Trainees will gain wider experience of the role and application of reconstructive science in supporting patients requiring prosthetic and surgical treatment for congenital craniofacial deformities.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1, 3, 4, 5	Competency Explain to a patient the procedure for the provision of a prosthesis to treat their deformity, address any procedure-related questions and provide information on how to manage their prosthesis.	Action View
# 2	Learning outcome 1, 3, 4, 5	Competency Gain informed consent and plan the clinical examination of the patient in accordance with local/professional guidelines, adapting techniques as necessary to reflect possible outcomes and influencing factors.	Action View
# 3	Learning outcome 1, 3, 4, 5	Competency Treat patients in a way that respects their dignity, rights, privacy and confidentiality.	Action View
# 4	Learning outcome 1, 2, 3, 4, 5, 6, 7, 11	Competency Minimise risks and hazards in compliance with health and safety policies, performing contamination control and infection prevention.	Action View
# 5	Learning outcome 3	Competency Record a comprehensive and contemporaneous patient history, recognising the significance of changes in the patient’s reported health status and taking appropriate action.	Action View
# 6	Learning outcome 4	Competency Plan the treatment with the patient, referring patients for advice or alternative/adjunct treatment where appropriate.	Action View
# 7	Learning outcome 5	Competency Discuss possible treatment plans for patients with maxillofacial trauma with senior clinical colleagues, recognising the impact on the patient, relatives and carers.	Action View
# 8	Learning outcome 5	Competency Discuss possible treatment plans for patients  with  craniofacial deformities with clinical colleagues, recognising the impact on the patient relatives and carers.	Action View
# 9	Learning outcome 6	Competency Plan, design, manufacture and evaluate dental devices for patients with fractures involving the mandible, maxilla and middle third of the facial skeleton.	Action View
# 10	Learning outcome 6	Competency Discuss treatment options with respect to devices for patients with dentoalveolar trauma.	Action View
# 11	Learning outcome 6	Competency Plan and manufacture devices for a patient with a single avulsed tooth.	Action View
# 12	Learning outcome 6	Competency Plan and manufacture devices for a patient with multiple dental alveolar injuries.	Action View
# 13	Learning outcome 6	Competency Plan and manufacture devices for a patient requiring soft bite guards for concussed teeth.	Action View
# 14	Learning outcome 6	Competency Plan and manufacture arch bars for dentate patients with mandibular fractures.	Action View
# 15	Learning outcome 6	Competency Plan and manufacture arch bars for dentate patients with mandibular fractures and edentulous saddles.	Action View
# 16	Learning outcome 6	Competency Plan and manufacture splints for edentulous patients with mandibular fractures.	Action View
# 17	Learning outcome 7	Competency Explain and discuss treatment options for patients with congenital absence of pinna (ears) that require an auricular (ear) prosthesis with patients, their carers or relatives and colleagues as appropriate.	Action View
# 18	Learning outcome 7	Competency Prepare the patient and take impressions of patients to generate analogues for a range of defects.	Action View
# 19	Learning outcome 7	Competency Design, plan, manufacture, fit and evaluate an adhesive retained auricular (ear) prosthesis for a patient with congenital absence of pinna (external part of the ear).	Action View
# 20	Learning outcome 7	Competency Plan alternative types of auricular (ear) prostheses for patients with congenital absence of pinna (external part of the ear).	Action View
# 21	Learning outcome 7	Competency Fit a range of auricular (ear) prostheses for patients with congenital (external part of the ear). Discuss prosthesis management with the patient, carer, or relative.	Action View
# 22	Learning outcome 8	Competency Discuss treatment options and plans with senior surgical and scientific colleagues for bi-maxillary orthognathic surgery (jaw surgery). Observing discussions with patients, their carers or relatives, and outline the procedures and complications related to the treatment options.	Action View
# 23	Learning outcome 8	Competency Generate pre-surgical plans for patients requiring bi-maxillary orthognathic surgery (jaw surgery).	Action View
# 24	Learning outcome 8	Competency Complete, interpret and analyse a two-dimensional surgical plan for a bimaxillary osteotomy (cephalometric analysis and plan).	Action View
# 25	Learning outcome 8	Competency Complete, interpret and analyse a three-dimensional surgical plan for a bi-maxillary orthognathic surgery (model analysis and plan).	Action View
# 26	Learning outcome 8	Competency Plan and manufacture a surgical inter-occlusal wafer for bi-maxillary orthognathic surgery.	Action View
# 27	Learning outcome 8	Competency Recognise and classify malocclusions and bi-deformities.	Action View
# 28	Learning outcome 8	Competency Recognise and classify malocclusions and apply this to the planning for the surgical treatment of dentofacial defomities.	Action View
# 29	Learning outcome 8	Competency Appreciate and apply the technical management of the cleft palate patient.	Action View
# 30	Learning outcome 9	Competency Manipulate, analyse and interpret three-dimensional data of the head and neck for patients requiring orthognathic surgery.	Action View
# 31	Learning outcome 9	Competency Use Dicom data to reconstruct 3D images and apply methods of image manipulation to 3D data sets.	Action View
# 32	Learning outcome 9	Competency Prepare the manufacture of model analogues from 3D data sets.	Action View
# 33	Learning outcome 10	Competency Identify different material options in relation to surgical repair of the skull from alloplastic (not human tissues, i.e. metal) and autogenous (patient’s own tissue) sources.	Action View
# 34	Learning outcome 10	Competency Discuss material selection for the surgical repair based on patient aetiology, laboratory choices, surgical choices and accessibility of materials for manufacture.	Action View
# 35	Learning outcome 10	Competency Explore material choice in relation to different types of tissue to be replaced, either bone (hard), or muscle or skin (soft).	Action View
# 36	Learning outcome 10	Competency Manufacture medical implants for patients requiring titanium cranioplasty (surgical repair of a defect or deformity of a skull).	Action View
# 37	Learning outcome 10	Competency Manufacture and provide a deep- buried implant recognising the use of 3D data, correct anatomical shape, production of the defect bone analogue, post processing the surface for improved biocompatibility, placement and fixation.	Action View
# 38	Learning outcome 10	Competency Manufacture alloplastic implants to a standard suitable for implantation.	Action View
# 39	Learning outcome 10	Competency Evaluate the fitness for use of implanted devices used in craniofacial surgery and attend operating theatre to see the use of the implant.	Action View
# 40	Learning outcome 10	Competency Apply the regulatory factors affecting the recording and provision of deep-buried implants.	Action View
# 41	Learning outcome 11	Competency Identify and navigate the standards that underpin or are used within the organisation’s medical device management strategy and associated service delivery.	Action View
# 42	Learning outcome 11	Competency Assist in the routine maintenance and calibration of equipment used to plan and make medical devices producing accurate records in accordance with relevant legislation and guidance.	Action View
# 43	Learning outcome 11	Competency Assist in the routine quality assurance procedures on the equipment used to plan and make medical devices producing accurate records in accordance with relevant legislation and guidance.	Action View

Assessments

You must complete:

• 5 case-based discussion(s)
• 5 of the following DOPS/ OCEs:

Fabricate custom made metal arch bar splints.	DOPS
Fabricate custom made arch bar splints with Gunning type extension.	DOPS
Position models of dental arches in ideal post operative position for bimaxillary orthognathic surgery planning.	DOPS
Pack silicone into mould to produce and ear prosthesis.	DOPS
Take relevant medical history, discuss a treatment plan with a patient and obtain informed consent.	OCE
Trial fit intermediate and final position PMMA occlusal splints prior to surgery	OCE
Fit an ear prosthesis and instruct patient in use of fixation system.	OCE

Learning outcomes

1. Observe informed consent and assist in planning the treatment of the patient who has experienced maxillofacial trauma in accordance with local/professional guidelines, adapting techniques as necessary to reflect possible outcomes and influencing factors.
2. Observe informed consent and assist in clinical assessment of a patient who has a craniofacial deformity in accordance with local/professional guidelines, adapting techniques as necessary to reflect possible outcomes and influencing factors.
3. Record a comprehensive and contemporaneous patient history recognising the significance of changes in the patient’s reported health status and taking appropriate action.
4. Write a treatment plan for patients who have experienced maxillofacial trauma or have a craniofacial deformities in partnership with the patient, supporting the patient to manage their fear and anxiety, and referring to other support services for advice or alternative/adjunct treatment where appropriate.
5. Discuss and agree treatment plans for a range of patients referred to the unit with maxillofacial trauma or craniofacial deformities with clinical colleagues, the patient and, if appropriate, relatives or carers.
6. Plan, design, manufacture and evaluate dental devices for patients with fractures involving the mandible, maxilla and middle third of the facial skeleton.
7. Discuss treatment options, design, plan, manufacture, fit and evaluate a range of auricular (ear) prostheses for patients with congenital absence of pinna (external part of the ear) prosthesis with the patient, their carers or relatives, and colleagues, as appropriate.
8. Discuss treatment options and plans with patients, their carers or relatives, and colleagues for bimaxillary orthognathic (jaw) surgery and generate pre- surgical plan.
9. Manipulate, analyse and interpret 3D digital imaging data of the head and neck for patients requiring orthognathic surgery.
10. Manufacture medical implants for patients requiring surgical repair.
11. Assist in the routine maintenance, calibration and quality assurance procedures on the equipment used to plan and make medical devices.

Learning outcomes

1. Describe the scientific principles underpinning the use of materials and biomaterials and discuss their limitations and selection.
2. Relate the composition, structure, processing and behaviour of metallic, polymeric and ceramic biomedical materials to the design and manufacture of medical devices.
3. Analyse the possible reasons for failure and breakdown of implants and actions that can be taken to reduce this risk.
4. Evaluate the underlying risk, legal and ethical requirements in the manufacture of medical devices.
5. Apply theoretical principles of materials properties and performance in the design and manufacture of medical devices.
6. Analyse and manipulate digital data associated with the design of alloplastic implants (non-biologic material such as metal, ceramic and plastic).
7. Select and apply appropriate materials and techniques to create 3D analogues of human tissues for the study and manufacture of medical devices.
8. Discuss the principles of tissue engineering as an alternative to alloplastic implants.
9. Discuss the risk management and governance framework for prototype medical devices in healthcare.
10. Critically analyse new developments and scientific advances in biomedical materials, manufacturing techniques and clinical performance, and discuss their application for new and innovative treatments.
11. Discuss physical and psychological factors associated with altered body image of patients with congenital facial deformities.
12. Explain the potential routes of transmission of infectious agents in clinical practice, mechanisms for the prevention of infection, the scientific principles of decontamination and disinfection and their relevance to health and safety policies.
13. Compare and contrast the range of physical and psychological responses to illness exhibited by patients and their families in response to maxillofacial trauma and/or craniofacial deformities and the treatments and support mechanisms available.
14. Discuss and evaluate the role of members of the multidisciplinary team involved in the treatment and rehabilitation of patients with head and neck cancer and soft tissue injuries, including speech therapy, dentistry, clinical psychology and self-help/charities, etc.
15. Describe the epidemiology, causes, incidence, classification and preventative strategies with respect to fractures of the maxilla and middle third of the facial skeleton.
16. Discuss the factors influencing clinical decisions with respect to treatment and rehabilitation following a range of typical dental or facial fractures.
17. Describe congenital deformities/absence of the ear and their reconstruction surgically and prosthetically.
18. Explain and justify the selection of a treatment plan for a range of patients requiring auricular (ear) prostheses based on the patient assessment and diagnosis.
19. Discuss the use of implant retention for patients with congenital absence of pinna (ear) and the use of external and bone-anchored hearing aids.
20. Discuss the factors affecting clinical decisions in the treatment of orthognathic (jaw) and craniofacial surgery.
21. Integrate the recognition and aetiology of congenital and acquired craniofacial deformities and analyse skeletal and dental deformities using manual and computer-aided analysis techniques, and evaluate and apply planning systems for orthognathic surgery.

Indicative content

Deep-buried implants

• Physiological and immunological responses to alloplastic implants
• Cellular response to implants, systemic effects of implants
• Blood compatibility, non-thrombogenic surfaces
• Testing of carcinogenicity, risk assessment

Metallic implant materials

• Titanium and titanium-based alloys
• Types and composition
• Structure and properties
• Implant manufacture with titanium and titanium-based alloys

Ceramic implant materials

• Calcium phosphate, structure, properties of hydroxyapatite, manufacturing of hydroxyapatite

Polymeric implant materials

• Polymeric implant materials, rubbers
• Deterioration of polymers, chemical effects, sterilisation effects, mechano- chemical effects, in vivo environmental effects, stability and toxicity

Failure of materials

• Behaviour of materials when stressed
• Different ways in which materials can fail (wear, fatigue, degradation by corrosion)
• Corrosion of metallic implants
• Electrochemical aspects
• Pourbaix diagrams in corrosion
• Rates of corrosion and polarisation curves
• Corrosion of available metals
• Minimisation of corrosion
• Relationship of failure to the macro- and microstructure of a material
• Role of defects in metals and the effect on an appliance

Soft tissue replacement

• Percutaneous devices
• Maxillofacial implants
• Ear and eye implants
• Space-filling implants

New developments in biomedical materials and manufacturing

• Surface coatings of implant materials, e.g. plasma coatings, hydroxyapetite coatings
• Physical and vapour deposition of thin films
• Evaluation of chemical and mechanical properties of new materials and their application
• Principles of tissue engineering, stem cell research and its application to hard and soft tissue reconstruction
• 3D printing of substrate structures, materials for scaffolds
• Hard tissue growth, soft tissue growth
• Comparisons with alloplastic materials and manufacture
• 3D printing of metallic implants, laser sintering

Fixation

• Interface problems, bone cement, porous ingrowth, direct bonding, interface and passive fixation
• Effects of fixation on implant function

Patient selection and management

• The implant patient: aetiology and assessment of condition

• Medicolegal implications of implantable prostheses; EU, US and UK legislation for implantable prostheses

• Sterilisation techniques

 

• Effects of sterilisation techniques on physical and chemical properties of implants
• Microbial contamination
• Effects of contamination
• Manufacturing techniques of custom-made alloplastic implants
• Effects of manufacturing techniques on the properties of implants
• Calculation of physical dimensions of alloplastic implants relating to mechanical and chemical properties of the material selected
• Effect of bone density on fixation design 

3D data

• Different modalities of obtaining digital data (CT, MRI, surface data acquisition) and new developments in imaging
• 3D volumetric and 3D surface data acquisition
• Comparative analysis of methods of obtaining 3D data and accuracy
• Identification of principle anatomical structures on X-rays, CT, MRI and surface data scans
• Principles of image-guided surgery and its applications in maxillofacial and craniofacial surgery
• Dicom data, conversion to 3D data and 3D images
• Anatomical landmarks and artefacts for the different methods of data collection
• Accuracy of 3D reconstructed images
• 3D dimensional software programs available for pre-operative planning and image manipulation and assessment in pre/postoperative outcomes
• 3D software systems to predict ideal implant locations (i.e. Simplant)
• 3D templates to locate implants at surgery

Anatomical models

• Anatomical models from 3D data (i.e. CNC milling – computerised numerical controlled, rapid prototyping techniques)
• Manufacture and accuracy of 3D models used to create facial prostheses, cranioplasties and templates

Trauma

• Fracture sites of the facial skeleton
• Displacement of fractures
• Principles of treatment
• Laboratory-constructed fracture fixation devices
• Soft tissue injuries, treatments and devices
• Principles of management and technology for maxillofacial trauma
• Sports injuries and prevention
• The management and technical support for soft tissue injuries
• Post-traumatic rehabilitation
• Analysis of bone density, effect of age, bone density and mechanical properties of bone
• Mouth protectors
• Dental trauma, displacement injuries, splinting of traumatised teeth, trauma devices, arch bars (nickel silver, chrome cobalt, stainless steel), cast splints
• Metal-joining techniques

Orthognathic surgery planning

• Craniofacial and jaw deformities
  • Cleft lip and palate: incidence, aetiology, treatment
  • Surgical techniques for orthognathic surgery
  • Distraction osteogenesis
• Model-based pre-operative planning systems, computer-aided planning systems
• Design principles for devices and surgical aids for orthognathic surgery

Surgical procedures and devices

• Theatre protocols
• Surgical procedures relevant to orthognathic and craniofacial surgery 

Anaplastology

• Principles of the clinical management of auricular prostheses:
  • pre-treatment assessment
  • treatment planning
  • pre-prosthetic surgery
• Principles of auricular prosthesis design
• Implant retention for auricular prostheses, materials selection for one-piece stud/implant-retained prostheses
• Integration of colour technology, material and colour stability
• Impression techniques and materials 

Medical legal aspects

• Medical legal aspects of treating patients, patients’ complaints procedures, carers
• Personal Protective Equipment regulations
• Medical history and records, patient and professional communication
• Medical ethics
• Informed choice/consent/negligence and maxillofacial prosthetics practice 

Risk management and governance

• National and international standards and guidance
• Compliance with the requirements of the Medical Devices Directive (MDD)
• The requirements of the MDD and the application of these and technical standards to the safety and performance of medical devices
• Device classifications
• Clinical Governance framework
• Current standards and compliance in the healthcare environment, including Standards for Better Health, NHS Litigation Authority
• Management of innovation and prototypes

Patient management

• Patient evaluation and referrals
• Management of patient’s fears/anxiety
• Theories of health-related behaviour and effects of drugs, allergies and lifestyle factors on patient health and rehabilitation
• Common psychosocial disorders associated with congenital facial deformities (abnormal psychology, anxiety, depression, psychoses)
• Basic counselling and communication skills
• Support groups (physical and internet)

Activities

• Experience a range of clinical services and in each setting identify how each service contributes to a holistic approach to  patient care, and discuss potential improvements to enhance patient safety, dignity and care. These experiences should take place across the two specialist modules and should usually include:
  • accident and emergency, including the initial patient assessment
  • oral and maxillofacial trauma clinics, including observation of diagnostic procedures and a range of imaging techniques
  • diagnostic services (radiography, CT, MRI)
  • operating theatres, including observing surgery for: (i) reduction and fixation of mandibular fractures; (ii) reduction and fixation of dental injuries; (iii) the insertion of facial osseo-integrated implants; (iv) exposure of facial osseo-integrated implants; and postoperative review of patient who had: (i) mandibular fractures and (ii) dental injuries
  • trauma and inpatient areas, including the observation of postoperative graft care
  • post-trauma review clinics
  • pre-surgical orthodontic clinics
  • orthognathic surgery assessment and planning clinics
  • facial prosthetic clinics
  • cleft lip and palate clinics
  • reconstructive clinics for the management of congenital deformities
  • diagnostic services (cephalometry, CT, 3D imaging, medical photography)
  • operating theatres
  • postoperative review clinics.
• Observe the manufacture of trauma devices for a range of patients and discuss the experience of patients with a small number of patients, identifying areas of good practice and potential areas for improvement, including an action plan to support any identified improvement.
• With permission, follow a patient’s treatment from assessment to theatre (above) and subsequently the follow-up review after insertion of the implant, and discuss with the patient their positive experiences and areas they feel could be improved upon.
• Attend a range of multidisciplinary team meetings where the diagnosis and treatment of patients referred to a reconstructive science service would be discussed, and reflect on the benefits of a multidisciplinary approach to patient care.
• Visit a range of settings where medical artists contribute to traditional and digital illustration to facial reconstruction for research and forensic science and discuss how the techniques can contribute to reconstructive science. 
• Prepare and present a clinical audit, research or service improvement project to colleagues and gain formal feedback from the audience to generate an action plan to develop your presentation skills.