Dentists have a great treatment for snoring and sleep apnea and one in four of their patients suffer from these conditions. But, their patients often get lost in a diagnostic process that is expensive and time consuming, often resulting in the patient not receiving care. Dr Ken Berley DDS, JD created an informed consent protocol that gives dentists a path to start sleep treatment today and send the patient for diagnosis tomorrow.

1. Provisional Mandibular
Advancement (PMAD) Therapy
Randy Clare, Sr. Director Brand and Product
March 2019
A protocol based on the work and writings of, and discussions with, Ken Berley, DDS, J.D.

2. Snoring…
• Snoring is noisy breathing during sleep. Snoring affects approximately
90 million Americans (35 million on a regular basis).
• Snoring is the sound that a partially obstructed airway makes.
• As the patient falls asleep, the muscles of the airway relax, the tongue
falls backward and the airway narrows. As air passes through the
narrow airway, the tissues vibrate, which makes the characteristic
sound of snoring. The narrower the airway becomes, the greater the
vibration and the louder the snoring.

3. STOP-Bang Questionnaire
• The STOP-Bang questionnaire is a
proven tool that can be used to
screen for obstructive sleep apnea
(OSA). This tool will assess if you
are at low, moderate or high risk for
sleep apnea.
http://www.stopbang.ca/osa/screeni
ng.php

4. Provisional
provisional
adjective
pro·​vi·​sion·​al | prə-ˈvizh-nəl, -ˈvi-zhə-nᵊl
Definition of provisional (Entry 1 of 2)
: serving for the time being : TEMPORARY
// a provisional government
provisional
noun
Definition of provisional (Entry 2 of 2)
: a postage stamp for use until a regular issue appears— compare DEFINITIVE

5. Working Diagnosis
• Preliminary diagnosis, provisional diagnosis, decision-making; a
diagnosis based on experience, clinical epidemiology, and early
confirmatory evidence provided by ancillary studies (e.g., radiologic
findings).
• Working diagnosis allows for early disease management, while awaiting
special or more definitive studies.
• Working diagnosis is a provisional diagnosis of the most likely nature of
a disease (prior to confirmation by laboratory diagnosis and or testing
results).
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The
McGraw-Hill Companies, Inc.

6. What Is PMAD?
• Patients who snore may have sleep-disordered breathing (SDB).
• Chronic snoring is associated with high risk of sleep apnea.
• Sleep apnea is a condition that can be life-threatening.
• Dentists are not trained or legally qualified to determine if a patient is
simply snoring or is suffering from sleep apnea.
• Only a physician is legally qualified to evaluate and diagnose sleep
apnea.
• PMAD involves the temporary dental treatment of sleep-related
symptoms until a physician’s diagnosis is obtained.

7. Informed Consent
• The process of informed consent occurs when communication between a patient
and physician results in the patient’s authorization or agreement to undergo a
specific medical intervention.
• Assess the patient’s ability to understand relevant medical information and the
implications of treatment alternatives and to make an independent, voluntary
decision.
• Present relevant information accurately and sensitively, in keeping with the patient’s
preferences for receiving medical information. Include information about:
• Diagnosis (when known)
• Nature and purpose of recommended interventions
• Burdens, risks and expected benefits of all options, including forgoing treatment
• Document the informed consent conversation and the patient’s decision in the
medical record in some manner. When the patient has provided specific written
consent, the consent form should be included in the record.

9. PMAD – Silent Nite® sl
• Silent Nite® sl works by
protruding patient’s lower jaw
and tongue while sleeping.
• Protruding patient’s jaw
should help keep the airway
open.
• Silent Nite sl should be used
as a provisional appliance
anytime the patient sleeps
until they are provided with a
definitive therapy.

10. PMAD – EMA®
• EMA® works by protruding the
patient’s lower jaw and tongue while
sleeping.
• Protruding the patient's jaw should
help keep the airway open.
• EMA should be used as a provisional
appliance anytime the patient sleeps
until they are provided with a definitive
therapy.

11. Benefits of PMAD Therapy
(Silent Nite & EMA)
• Silent Nite and EMA appliances are well-fitting custom appliances.
• Both the Silent Nite and EMA can be used in combination with a CPAP.
• PMAD fabrication could minimize SDB symptoms until a definitive
diagnosis and treatment is initiated.
• PMAD fabrication could minimize legal risks associated with having a
patient with excessive daytime sleepiness who is untreated.

12. Problems with PMAD Therapy
• Provisional appliances must be paid for by the patient in cash. Since
only a sleep physician can provide a definitive diagnosis, medical
insurance benefits are NOT available. Without a diagnosis of OSA,
insurance cannot be filed.
• Only a small number of appliances can be provided quickly and
cheaply.
• Most temporary appliances may not fit well enough and are not durable
enough for this protocol.
• Dentists should NOT use a PMAD until they speak with a local sleep
physician who will oversee this patient.

13. Continuous Positive Airway Pressure
(CPAP)
• If a physician eventually prescribes a continuous positive airway
pressure (CPAP) device, your Silent Nite sl can be used in combination
with this device.
• CPAP in combination with the Silent Nite sl may allow for lower positive
airway pressure (PAP) and make the CPAP device easier to use.

14. No Guarantee of Success
• Silent Nite sl is very effective at minimizing symptoms associated with
sleep-disordered breathing.
• However, no medical protocol works 100% of the time.

15. Comorbid Conditions Associated with
Sleep-Disordered Breathing
• Coronary heart disease, high blood pressure, diabetes, cerebrovascular
disease, stroke, heart problems, heart attack, depression, mood
disorders, weight gain, obesity, gastroesophageal reflux (GERD),
cancer, sexual dysfunction, impotence, dementia, Alzheimer’s disease,
excessive daytime sleepiness, increased work- and traffic-related
accidents, death

16. Dental Issues
• Complications due to PMAD use have been minor.
• Patient may develop short-term muscle soreness.
• Sore teeth.
• Some level of jaw or tooth movement.
• Jaw shifts are common and can be prevented by diligent use of
morning aligner provided with the Silent Nite sl.

17. Silent Nite sl Adjustment
• Silent Nite sl has six different
lengths of advancement arms.
• When the appliance is
delivered, the patient will be
informed of the proper
technique and protocol for
adjusting the appliance.

18. EMA Adjustment
• The EMA appliance uses nine different
lengths of straps to gradually and
incrementally titrate the mandible
forward.
• Four different lengths of elastic straps
match the strength of pull to the
musculature of the patient.
• Four strengths are differentiated by
color: White = Soft, Yellow = Medium
Firm, Blue = Firm, Clear = Extra Firm

19. Alternatives to PMAD
• Continuous positive airway pressure (CPAP)
• Oral surgery
• Pharyngeal surgery
• Positional sleep therapy
• Weight loss
• Exercise

20. One for Home, One for Travel
• Only three days in the lab for improved
wait times and patient satisfaction.
• More than 400,000 Silent Nite sl
appliances delivered.
• Cost effective two-pack helps ensure
patients never go untreated.

21. Acknowledgement and Resources
• This material was prepared using an informed consent document developed by
Ken Berley, DDS, J.D. Click here to download the source document for your
practice: https://glidewelldental.com/informed-consent
• The STOP-Bang questionnaire is a proven tool that can be used to screen for
obstructive sleep apnea (OSA). This tool will assess if you are at low, moderate or
high risk for sleep apnea: http://www.stopbang.ca/osa/screening.php