ADA2022 MouthguardFabrication
ADA2022 MouthguardFabrication
ADA2022 MouthguardFabrication
Principal Editors
Dr Brett Dorney
Professor Martin Tyas AM
Substantial assistance in the preparation and development of earlier editions of these Guidelines was provided by:
Dr Brian Bishop
Mr John Kenyon-Smith
Associate Professor Paul McCrory
Dr Helen Cornwell
The Australian Dental Association wishes to express its gratitude for their efforts in the publication of these Guidelines.
Published by the Australian Dental Association PO Box 520, St Leonards, NSW 1590, Australia
© Australian Dental Association 2022
All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or
mechanical, including photocopying, without the written permission of the publisher.
ISBN: 978-0-646-90228-9
Foreword 4
Introduction 5
Types of mouthguards 6
Wearing of mouthguards 6
Benefits of mouthguards 7
General design principles 7
General principles for materials 8
Integrity of materials 8
Advice on use and maintenance 8
Appendix A 9
References 12
Several recent systematic reviews1, 2 have looked at the One study provided evidence to suggest a protective effect
clinical efficacy of mouthguards in the prevention of sporting of mouthguard use on concussion severity as measured by
injuries. The search strategies revealed over 2,250 citations time loss from unrestricted participation, however it did not
for mouthguards and head injury. Comparison of published measure individual mouthguard exposure and therefore
studies is difficult given the variability in research designs, could not provide a measure of relative risk.11
selection bias, definition of injury, mouthguard types, Three cohort studies12-14 found no significant difference
measurements used to assess mouthguard exposure and between concussion rates, and one additional study
injury, risk compensation and the variety of sports assessed examined concussion rates between football players wearing
which have differing head injury risk. custom-made versus non-custom mouthguards and thus did
not examine risk differences between users and non-users.15
Biomechanical studies have suggested a protective role of
mouthguard use in reducing sporting impact-related forces Only one randomised controlled trial (RCT) has been
to the head.3, 4 Two papers have been universally cited in the conducted in this area, which assessed head and orofacial
concussion prevention literature to support mouthguard use injury rates in Australian Rules football using two study arms
as an effective means of preventing concussion, however (custom laminated mouthguard versus usual mouthguard
both of these papers are methodologically limited.3, 5 behaviours).16 The authors stated that the study was
Hickey et al.3 revealed a reduction in the amplitude of bone underpowered to determine injury risk for orofacial injury
deformation and intracranial pressure by approximately 50 and there was no report of concussion rates for each study
per cent with the use of a mouthguard, whereas Takeda et arm. Thus, the true association between mouthguard use
al.4 showed that mouthguard use significantly decreased and concussion risk could not be ascertained. At the same
the distortion of the mandibular bone and the acceleration time, there is evidence to support the use of mouthguards
of the head compared with no mouthguard use. Stenger for orofacial and dental injury protection.17 Such findings
et al.6 also recommended mouthguards based on their justify the use of mouthguards and facial protection in
anecdotal experience of mouthguard use in US collegiate collision sports as a means to reduce injuries, but at this
football. While biologically plausible, particularly with regard time cannot be advocated specifically for concussion risk
to orofacial injury, detailed concussive impact biomechanical reduction.
studies show that mandibular impact accounts for a small
Future studies must not only be methodologically rigorous
percentage of all concussive injuries and this may be why
and statistically powered but must address the different
few prospective studies demonstrate a role for mouthguards
types of mouthguard on the market and their relative
in prevention of brain injury.7
efficacy in reducing or preventing injury.18, 19
However, recent laboratory research8 showed that
This document provides guidance on the fabrication of
mouthguards can reduce distortion to the mandible and the
sports mouthguards and includes information to be given
acceleration of the head from the same blow, and therefore
to users of mouthguards on their use and maintenance.
may have the potential to prevent mandibular bone fractures
Appendix A gives guidance on the methods of fabrication
and concussion. The proven benefit of a mouthguard is
of custom-made maxillary mouthguards and bimaxillary
the dissipation of the forces delivered to the maxilla, skull
mouthguards
and temporomandibular joint complex when the mandible
receives a blow.9 There is also stabilisation of the skull
through increased neck muscle activity by clenching on the
mouthguard, as well as a benefit from the altered position of
the condyle in the fossa.10
Numerous studies on mouthguard efficacy include cross-
sectional surveys, case reports, case series and retrospective
studies, and these have shown conflicting results. There
were five prospective cohort studies that assessed the
relation between mouthguard use and concussion rates.
A mouthguard is a protective device worn in the upper jaw Custom-made mouthguards (formed on a cast of the
and sometimes the lower jaw, to reduce injuries to the teeth, wearer’s jaws) are the most acceptable. Mouth-formed and
jaws and associated soft tissues. Types include: stock mouthguards have disadvantages with respect to
possible lack of retention, single-tooth contact, inadequate
Custom-made mouthguard thickness, lack of retention and often rapid material
Custom-made mouthguards are formed on a cast of the deterioration with a consequent risk of injury. Critical for
upper jaw, sometimes in conjunction with a cast of the injury prevention, the mouthguard should have an ideal
lower jaw, to obtain even occlusal contact and are produced thickness after fabrication of 3 mm, and provide an occlusal
using appropriate materials. surface balanced to the mandibular teeth.
Such mouthguards fit poorly, are difficult to wear, thin The mouthguard can be constructed of two layers of EVA,
out dramatically, provide poor protection, are difficult pressure laminated together; the base layer 3 mm thick, and
to adapt to the mouth’s anatomy, may be dislodged the outer layer 2 mm thick. Custom-made professionally
during use with a consequential risk of airway fitted mouthguards should be considered as a part of
obstruction20 and are therefore not recommended. children’s sporting team uniform.
Mouth-formed “shell-liner” guards, which have a rigid Patients undergoing orthodontic treatment should be
outer layer and a soft thermoplastic inner layer, are also provided with custom-made mouthguards.
not recommended as the hard outer layer may amplify
impact force and cause injury. 20 Biocompatibility
Stock mouthguard Mouthguard material should not constitute a biological or
toxicological hazard with respect to infection or irritation
Another “off-the-shelf” variety, these mouthguards consist
of normal oral mucosa, and should not contain elements or
of a curved trough of plastics or rubber and are worn
components toxic to oral tissues.
without modification or adaptation. Such mouthguards fit
poorly, are difficult to wear, provide poor protection,
may be dislodged during use with a consequential risk NOTE: Further guidance may be found in ISO 7405,
of airway obstruction20 and are not recommended. Dentistry—Preclinical evaluation of biocompatibility of
medical devices used in dentistry—Test methods for dental
materials and ISO 10993-1, Biological evaluation of medical
devices, Part 1: Evaluation and testing.
The benefits of wearing a sports mouthguard include The general design principles for sports mouthguards are:
reducing: • For sports where high occlusal loads are to be expected,
• the risk of injury to the maxillary and mandibular the mouthguard should enclose the maxillary teeth,
anterior teeth. preferably to the distal surface of the second molar.
• damage to the posterior teeth of either jaw following For these design requirements a mandibular model will
a traumatic closure of the mandible. be necessary to obtain an even occlusal contact.
• intraoral and perioral lacerations. • For standard club sports, enclosing the maxillary teeth to
• tongue damage at impact. the distal surface of the first molar is usually sufficient.
• fracture of the body of the mandible and the • In the mixed dentition, the mouthguard should extend
mandibular condyles. to the distal surface of the maxillary first molar.
• damage to the temporomandibular joint. • The approximate material thickness should be 2-3 mm on
the labial aspect, 3 mm on the occlusal aspect and 2 mm
on the palatal aspect.
• The labial flange should extend to within 2 mm of the
vestibular reflection.
• The palatal flange should extend about 10 mm above
the gingival margin.
• The edge of the labial flange should be rounded in
cross-section.
• The edge of the palatal flange should be tapered in
cross-section.
• On closing the mouth, there should be even contact
between the mouthguard’s occlusal surface and the
lower teeth.
• For laminated mouthguards, improved impact force
dispersion occurs when an airspace is created over the
anterior teeth.8
• Mouthguards should not be designed and constructed
with hard inserts sandwiched between laminations. 22
• Mouthguards should be thoroughly inspected prior
to being issued to ensure adequate thickness, resilience
and minimum pressure on the soft tissues.
Examination and impressions 5. Allow the model and thermoformed EVA blank to cool
for mouthguards thoroughly (normally 15 minutes), trim the periphery
to the outline with an electric knife or hot scalpel. (A
Mouthguards should be constructed following a number 11 scalpel in a metal handle produces the best
thorough clinical examination, including radiographs and cleanest outline). Only extend the mouthguard to the
where appropriate. Mouthguard design should take into distal surface of the upper first molars, unless upper and
lower models are needed for even occlusal contact.
consideration previously traumatised teeth and areas where
tooth eruption is expected. 0. Shape and smooth the periphery using abrasive wheels.
1. Finish with a soft polishing disk or mounted silicone
The occlusal pattern, soft and hard tissue pathology and the point.
temporomandibular joint should also be assessed.
2. Adjust the mouthguard to provide even contact between
its occlusal surface and the lower teeth on closure of
Impressions should be taken by a suitably trained dental the mandible.
professional and where necessary a registration of the
occlusion should be made. For orthodontic patients, wax can NOTE: TThis adjustment can be made in the mouth after
be used to block out orthodontic brackets, bands and wires first softening the occlusal surface preferably with a hot
during impression taking, and plaster or light-curing resin air pen or a small flame; or using articulated casts in the
can be used on the cast to block out brackets, bands and laboratory or at the chairside. The laboratory method allows
wires still visible after the initial impressions. It is unlikely that better control of the final thickness of the mouthguard and
a custom-made mouthguard will interfere with orthodontic there is no risk of burning the patient. Only very experienced
tooth movement, however regular review of the mouthguard operators should use the direct heat technique.
fit should be undertaken during the treatment period.
Laminated Mouthguard
A.1. Maxillary mouthguards The following procedure is a recommended method for the
fabrication of a laminated custom-made mouthguard:
Custom-made mouthguards may be fabricated using either 1. Prepare a gypsum cast of the wearer’s upper jaw to the
pressure-forming or vacuum-forming machines. Each type full depth of the sulcus and the hard tissue landmarks of
of machine has advantages and disadvantages. Particular the lower jaw.
features which are important are infra-red heating of the
2. Outline the periphery of the mouthguard on the upper
blank and full forming power (pressure or vacuum) should
cast with a marking pencil. (This outline is only useful
be achieved at the end of the heating cycle. when using either clear or semi-clear EVA mouthguard
blanks. Opaque colours such as black and white
Single-Layer Mouthguards completely mask the pencilled outline). (Additional steps
are required to add an airspace over the labial surface of
The following procedure is a recommended method for the the anterior teeth: soak the gypsum cast in water for 5
fabrication of a single-layer custom-made mouthguard: minutes; dry; add a 1 – 2 mm thick layer of plaster over
1.
Prepare a gypsum cast of the wearer’s upper jaw and the anterior teeth [canine to canine]; allow to set).
preferably also the lower jaw. 3. Cover the model with a water-based separator or a
2.
Outline the periphery of the mouthguard on the upper polyethylene high-shine foil.
cast with a marking pencil. (This outline is only useful 4. Heat a 3 mm EVA mouthguard blank by following the
when using clear or semi-clear EVA blanks. Opaque manufacturer’s instructions.
colours such as black and white will completely mask
the pencilled outline). 5. Thermoform and allow to cool (normally 15 minutes).
3.
Coat the model with a water-based separator or a 6. Trim the periphery to the outline with an electric knife
polyethylene high-shine foil. or a hot scalpel. (A number 11 scalpel in a metal handle
produces a cleaner more anatomical outline).
4. Form the mouthguard from either a 3 or 4 mm thick EVA
mouthguard blank, using a vacuum or pressure machine. 7. Degrease the first layer and the bonding surface of
the second mouthguard foil with an isopropyl alcohol
solution or roughen the bonding surface of the first EVA
blank with trimming wheels. Note that this step is critical
if using a coloured EVA blank as the second layer.
3. Thermoform a coloured 3 mm EVA blank as the 7. Pour up the alginate impressions in high-strength
second layer. gypsum.
4. Allow to cool; cut back following the initial outline 8. Form upper and lower mouthguards, extending each
established by the initial 2 mm clear blank. (This outline to include the second molars in each quadrant.
is visible even if the second layer is an opaque colour).
9. Smooth and trim both mouthguards.
Using fine abrasive polishers to remove the polished
surface of the coloured second layer blank. (A clear 10. Build up the occlusal surfaces of the lower first molars
second layer EVA blank does not require this step). with plaster to cusp height to resemble a small dome.
5. Thermoform using manufacturer’s instructions the third (This is to enhance retention of the lower mouthguard
layer using either a 2 or 3 mm thick EVA blank. by a suction cup effect). Do not extend the plaster onto
other surfaces.
6. Allow to cool, cut back the third layer to the already
established outline and articulate maxillary and
mandibular models to balance the occlusion, as
described in point 12 for laminated mouthguards.
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