The GEMPro Bruxism Monitor

DDME’s GEMPro Dentist’s Dilemma

Sleep apnea is a medical disease and cannot be diagnosed by a dentist. However,

tooth wear may be a result of sleep apnea. Dentists concerned about excessive

tooth wear cannot ignore airway disturbances much like dentists should not ignore

a suspicious lesion under the tongue. The GEMPro was developed to quantify the

severity of parafunctional activity and give dentists enough information about

airway disturbances to refer/resolve the patient correctly, minimizing potential

tooth wear.

“Dentists are encouraged to screen for airway issues” 2017

Major Dental Companies recognize the contribution of the

GEMPro and have elected to distribute:

Glidewell, Great Lakes, Whip Mix, Sleep Group Solutions

The Unmet Clinical Need in Dentistry

1. Bruxism – Presence and severity are NOT being diagnosed – (GEMPro does)

2. Occlusal Guards, based on published data, create unintended medical issues (GEMPro detects)

3. In many cases, bruxism causes can be identified leading to a differentiated treatment protocol (GEMPro does)

4. Restoration’s longevity can be improved by managing Bruxism related overloading (GEMPro helps)

5. 20-30% of all dental office adult patients have untreated airway issues which likely will result in excessive tooth wear (GEMPro can detect)

1. Bruxism – Presence and severity are NOT currently being diagnosed

GEMPro’s Unique EMG Calibration Establishes 2 Vectors of Evaluation

Frequency – How many and what type of parafunction

Magnitude – How strong is the parafunction

Calibration Graph: Documents Strongest Waking Bite Force

Bruxism Analysis (Acquisition Graph)

Waking Maximum Force

Sleeping Maximum Force

Bruxism Analysis (Process Graph)

Bursts Clenches and Grinds

Waking Maximum Force

Sleeping Maximum Force

2. Occlusal Guards, Based on Published data, Create Unintended Medical Issues

Any appliance placed in the oral cavity may change tongue and tissue locations

Independent research has validated changes in Sleep Apnea with Occlusal guards

Occlusal guards will help one of these patients and potentially hurt the other

The GEMPro answers these issues

Distinguish Between Airway Triggered Parafunction and Bruxism

Occlusal Splints may cause Significant Apnea

3. In many cases, bruxism causes can be identified leading to a differentiated treatment protocol

Parafunction in 4 minutes, note the correlation to Apnea Events

1. Distinguish between Airway Triggered Parafunction and Idiopathic Bruxism

2. Protect the dentition with maintaining the performance of the airway

3. Do NOT harm the patient with an inappropriate protective strategy

Airway Parafunction or True Bruxism

True Bruxism Airway Triggered Parafunction

Airway Parafunction or True Bruxism

True Bruxism Airway Triggered Parafunction

4. Restorations longevity can be improved by managing Bruxism related overloading

1. Avoid Overloading Risks

2. Identify the presence of Parafunction and manage your restoration risks

3. Distinguish between airway triggered parafunction and idiopathic Bruxism

4. Refer to sleep lab after your restoration when Airway issues are present

Which Appliance Will Protect Your Restoration?The one they will wear instead of sitting on the night stand

1. Airway related parafunction can be exacerbated by single arch guards

2. If a patient will not wear a guard, it may be because of their airway discomfort

3. Single Arch Splints are associated with increased airway complications(2).

4. Distinguish between airway triggered parafunction and TRUE Bruxism

1.

2.

Which Appliance Will Protect Your Restoration?

The One They Will Wear

The #1 Complication for Restoration Protection is Lack of Compliance

OverloadingArticles

Codes Associated with Guards and

Appliances

Description Code

Occlusal Guard (bruxism-grinding) D9951 Limited (equilibration)

Occlusal Guard (bruxism-grinding) D9952 Complete (equilibration)

Occlusal Guard Adjustment D9943

Occlusal Orthotic – Reduce Bruxism D7880 Reduction\Dislocation

Occlusal Orthotic Device Adjustment D7881

Sleep Apnea Appliance E0486 DME-Medical

Diagnostic Cast (impression) D0470

Patient’s with Oxygen Desaturations Oxygen desaturations alone do not diagnose OSA

However, OSA cannot exist without oxygen desaturations

Dental patients testing positive for oxygen desaturations with the GEMPro need to have follow up

DDME’s solutions for diagnosing OSA Purchase a Home Sleep Monitor + DDME Sleep Physician

GEMPro owners can refer their patients to DDME

DDME provides the Home Sleep Monitor

DDME’s Physicians provide a patient diagnosis for the dentist

This service is part of DDME’s Customer Service package

Refer to a sleep lab

Selling the Patient from the Dental Chair - Script Does the patient show signs of excessive Tooth Wear or Bruxism?

Yes – We have a new test that is performed at your home through the night. This test will give me information as to the cause of this tooth wear and allow me to give you the appropriate treatment protocol to protect your teeth. (approximately 50% of adult patients will test positive for potential airway disfunction and the dentist may intervene and positively improved the patients overall health and dentition)

No – Although you have no signs of excessive tooth wear at this time, we would like to screen you for the onset of abnormal parafunctional activity at night. Our office performs this test as a precautionary screen to insure your teeth stay healthy (approximately 20% of adult patients will test positive for potential excessive tooth wear and the dentist may intervene and positively improve the patients overall health and dentition before damage begins to occur)

Benefits to the patient: Patient’s dentist can differentiate between dental issues and potential medical issues Medical issues have large potential consequences if undetected and treated; cardiac disease, diabetes, depression,

weight gain, cancer. The dentist may positively impact the overall health of their patient. Patients gain information about their own sleep wellness, a subject that is in the news and generates significant

interest. Devices such as Fitbit etc. are increasing the public’s willingness to test for themselves.

Method of discussing with patient Mr. Patient. Dentists have been unable to diagnose night time grinding of the teeth until recently. At night,

your jaw muscles can fire at several times the magnitude you can make them fire when you are awake. This can be very destructive to your teeth. I would like to do a simple test on you to see if you are having this problem. With this test you and I will learn if your teeth are in danger of excessive wear or damage and if so, is it because of you snoring or stopping breathing at night, or is it caused by stress or other factors in your life. With this information, I can do the appropriate treatment protocol to protect your beautiful smile. (Show report) This is a sample report we will get from the test. This first graph will show us if your blood oxygen levels are compromised. If so this is a serious medical problem we will discuss, This graph tells me if your are clenching or grinding your teeth at night and how often and how hard. We have therapies that can protect your teeth if necessary. This graph tells me if you snore at night and how much and how loud. If you do we can address that condition also. The test is (FREE OR $50 OR $89) and very easy to do. Would it be ok if my staff shows what you need to do and sets you up with a night study?

Suggested approaches to positive GEMPro tests Patients with both Significant Parafunction and Oxygen Desaturations

If Oxygen Desaturations are significant (non artifact minimums under 85%, significant time under 88%), the patient should be referred/diagnosed for Sleep Apnea by a Sleep Physician. After treatment for Sleep Apnea (CPAP or Oral Sleep Appliance), retest to assure significant parafunctional activity does not exist. In many cases, the parafunctional activity will be minimized when Sleep Apnea is treated.

Dentition should be protected when significant number of events above 75% Maximum Waking Bite Force are present. An occlusal splint is suggested if Oxygen Desaturations are not significant. Occlusal Splints have been shown to both worsen and improve oxygen desaturations. After administering the appropriate tooth protection strategy, retest for Oxygen Desaturations. If still present or worse, refer/diagnose patient for Sleep Apnea. If referring, instruct patient and sleep lab that significant parafunctional activity is present. After treatment for Sleep Apnea (either CPAP or Oral Sleep Appliance), the patient should be retested while wearing therapy for the continued presence of significant parafunctional activity.

Patients with Significant Parafunction and no significant Oxygen Desaturations

Dentition should be protected when significant events above 75% Maximum Waking Bite Force are present. An occlusal splint is suggested if Oxygen Desaturations are not significant. Occlusal Splints have been shown to both worsen and improve oxygen desaturations. After administering the appropriate tooth protection strategy, retest for Oxygen Desaturations. If the Occlusal Splint created Oxygen Desaturations, refer/diagnose patients, noting to the diagnosing physician, the patient dentition should be protected. A different appliance selection might need to be made.

Whatever the results from the GEMPro, the dentist has intervened in determining if the Dentition is being subjected to damaging forces and if the overall health of the patient is potentially being compromised by an airway disfunction

Ease of Performing a Test

Patient Experience Patient enters 4 digit code to start

Only 2 sensors, a wrist watch and finger probe, EMG lead on cheek

Report may be emailed to dentist automatically in the morning or saved until the device is returned

Report is color coded to body position and shows Oxygen Saturation, Heart Rate, Parafunction of Masseter, and Snore

Two Bluetooth devices and tablet

Cost of Ownership

GEMPro’s purchase price is $1900.00

Cost per test is an EMG sensor, 50 sensors in a bag for $40/bag

Finger probe is reusable and cleaned with an alcohol swab between tests

DDME’s Optional Service Contract is $420/year

Unlimited technical and clinical support

Extended warranty for 1 year on all failures of devices

Retraining of Clinical Staff

Insurance on device if lost or stolen. All devices and case (except tablet) replaced with a $250 deductible. Tablet can be purchased from DDME or retail outlets.

Access to DDME’s Sleep Apnea Home test device if a medical diagnosis from a licensed Medical Sleep Physician is desired, $250/patient, DDME manages the patient ($200 discount)

DDME Partnerships

National exposure of this new technology device is growing

Glidewell, Spear Group, Great Lakes, Dr. Christensen are performing seminars

promoting GEMPro’s

Glidewell, Great Lakes, Whip Mix and SGS are distributing the devices from

seminars

DDME is creating a social media program, advertising, and video access programs

DDME wishes to partner with grass roots dental groups such as study clubs and

reginal meetings.