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Combination Therapy

Conflict of Interest Disclosure

Type of Potential Conflict Details of Potential Conflict

Grant/Research Support

Consultant

Speakers’ Bureaus

Financial support

Other President of Fusion Sleep Solutions. LLC

2. I wish to disclose the following potential conflicts of interest:

1. I do not have any potential conflicts of interest to disclose, OR

3. The material presented in this lecture has no relationship with any of these potential conflicts, OR

4. This talk presents material that is related to one or more of these potential conflicts, and the following objective references are provided as support for this lecture:

a. Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. JDSM, 2017;4(2):29–36.

"To raise new questions, new possibilities, to regard old problems from a new angle, requires creative imagination and marks real advance in science."

— Albert Einstein

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A Story for Dentistry

DALLAS REHABILITATION INSTITUTE

���������� ���� �

Post-polio patients

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“Lyon mask” (made by Respiratory Therapists )

Constant Volume ventilators set at 45 cmw !!!

Problem:

W. Keith Thornton, DDS

“I determined that not only could I improve the mask she brought in, but improve the whole technology using dental techniques”

Dorothy

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Deborah

“One of the biggest issues was the breathing while taking the impressions.”

John

• Body paralyzed except for two toes. • On a ventilator.• Had OSA.

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“ We think we have problems!

If this lady doesn’t inspire creative

solutions, then you might as well be

dead!”

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What isCombination

Therapy ?

Custom Face Mask

™

TAP-PAP nasal pillows

CombinationTherapy

Custom Face Mask

Custom Face Mask

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Combination Therapy: It is a combination of two therapies. 

OATCPAPPositionalMyofunctional TherapySurgeryHypoglossal Nerve Stim

Combination Therapy: It is a combination of two therapies. 

One: CPAP therapyTwo: Oral Appliance  

Therapy (OAT). 

Combination Therapy

Working with a Sleep MD

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CPAP (Continuous Positive Airway Pressure)

– Sleep MD

OAT (Oral Appliance Therapy)

– Sleep Dentist

A Review by the Positive Airway Pressure Task Force of the Standards of Practice Committee of the American Academy of Sleep Medicine› Long list of side effects› 51% compliance nationwide

Gay P; Weaver T; Loube D et al. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. SLEEP 2006;29(3):381-401.

CPAP interface: satisfaction and side effects› No difference in type or brand of interface, long list of side

effects.› “the majority of patients consider the use of the CPAP interface

disturbing…” Bachour, Vitikainen, Virkkula, Maasilta; CPAP interface: satisfaction and side effects; Sleep

Breath (2013) 17:667-672

Treatment efficacy: how well an intervention works under ideal controlled circumstances

Treatment effectiveness: how well an intervention performs in uncontrolled real world condition

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When treatment usage as a portion of the total sleep time is considered:

“While CPAP has a higher efficacy than OAT…

- OAT has a higher effectiveness than CPAP”

Sutherland K, Phillips CL, Cistulli PA, Efficacy versus Effectiveness in the Treatment of Obstructive Sleep Apnea: CPAP and Oral Appliances. JDSM 2015;2(4):175-181.

Objective Evaluation of Severity

And patient preference

American Academy of Sleep MedicineRamar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. Journal of Dental Sleep Medicine 2015;2(3):71–125.

1. Therapy more effective

2. Increase risks of side effects

Oral Appliance –moves the jaw forward

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Question:

What to do when monotherapy fails?

Prehn Definition of Combination Therapy

It is a CPAP interface to the nose or mouth or both, that either is in conjunction with a MAS or one that connects the CPAP hose directly to an oral appliance that features mandibular stabilization.

CT features:

• Superior stability due to being connected to the skull base via the dentition.

• Excellent compliance and satisfaction because of the lack of straps and leakage.

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REQUIRES:

the proper diagnosis and treatment by a Dentist trained in OAT.

OAT Failure

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CPAP Failure

��������I don’t think so!

+Type One – DUAL TherapyCombining Two Therapies

=

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•Achieves mandibular stabilization

•Easy to implement into a General Dental Practice

Type One – DUAL TherapyCPAP Combined with MAS

•No special training

•No management of CPAP (MD controls)

•Cost, insurance and chair time is a known and constant variable

Improved Outcome of Full Mask CPAP Treatment with Mandibular Stabilization Using A Dental ApplianceJerald H. Simmons, MD

SLEEP Journal Abstract 2010 Edition; #0478

10 patients (one drop out)1.Failed Full Face Mask2.Able to fabricate Snore Free (boil and

bite)3.Recognized improvement with MAS

6 Question survey before and after

Statistical improvement with combination (P < 0.001)

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Type Two – INTEGATED TherapyIntegrating Two Therapies

Type Two – INTEGRATED TherapyCPAP Connect Directly to MAS

• No straps

• Mandibular advancement not necessary, although advised

• Need special training with device

• Be familiar with CPAP Therapy

• Need to stock parts

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• Difficult to implement into General Dental practice

• Chair time varies-staff frustrations

• Insurance is unknown and not appropriate

0

2

4

6

8

10

1 23

45

Num

ber o

f Pat

ient

s

• CustomMask

• StockMask

More

Less

The New TAP-PAP Custom Face Mask for CPAP Compliance and SatisfactionRonald S. Prehn, DDS

SLEEP Journal Abstract 2010 Edition; #0459

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Who gets a Fusion Custom Mask?

Combination Therapy -Integrated Therapy

75 patients on combination therapy with a Custom Face Mask• Most often CPAP intolerant• CPAP intolerant patients had higher CPAP

pressures than others in study• CPAP pressures were reduced• Long term compliance (10yrs)• Long term cost less than stock mask

Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. JDSM, 2017;4(2):29–36.

Combination Therapy -Integrated Therapy

Conclusion: “The application of the CFM is for patients with more severe OSA and is well tolerated with improved compliance.

The CFM should be considered when other therapeutic methods of treating OSA have failed or when CPAP or the CPAP mask are intolerable to the patient”

Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. JDSM, 2017;4(2):29–36.

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Failed Therapy Number of Patients

TAP3 (OAT monotherapy) 11 (15%)

TAP-PAP CS (Type II CBT) 21 (28%)

CPAP (monotherapy) 43 (57%)

Study of 75 patients who had received a Fusion Custom Mask at my Dental Sleep Center 2009-2012

RS Prehn, T Swick, A Descriptive Report of Combination Therapy (custom face mas for CPAP integrated with a mandibular advancement splint) for long term treatment of OSA with literature review, JDSM 2017,4(2):29-36

Type II interfaces are aCLASS II Medical Device

TwoThings to Know…

United States Patent and Trademark Office An Agency of the Department of Commerce

Dr. Keith Thornton • Inventor• Patent Holder

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501(c) Approved Device

Exclusive License to fabricate, distribute and educate the Fusion Custom Mask

Ronald S. Prehn, ThM, DDS

Fusion Combination

SystemFusionCustomMask.com

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TAP - PAP CSNasal Pillows

Fusion Custom

Mask

Two styles of CPAP interfaces

TAP - PAP nasal pillow(Chairside)

Custom Face Mask(lab fabricated)

Monoblock

OR

TAP - PAP CS nasal pillow

• Simple to do chairside• Fully adjustable• Optional head set for hose• Works best CPAP under 15cm H20

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TAP - PAP CS

TAP - PAP CS

From TAP3 with TAP Post

From Fusion Monoblock

Fusion Custom Mask

1. Fusion Monoblock2. Screw on TAP post

2. Thermacryl upper and lower, slightly protruded

Phase one - Chairside

3. Take face impressionPhase two - Chairside

Prehn, R. and T. Colquitt, Fabrication technique for a custom face mask for the treatment of obstructive sleep apnea. J Prosthet Dent 2016;115(5):551-555.

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Phase two-Fusion Dental Lab

Fabricate FCM

Fusion Custom Mask

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• Validated superior compliance and satisfaction

• Can tolerate high pressures

• Can modify airflow to nose or mouth or both

• Adjustable

• Can lower CPAP pressure

Fusion Custom

Mask

Modified FCM

Who gets a Fusion Custom Mask?

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Failed Therapy Number of Patients

TAP3 (OAT monotherapy) 11 (15%)

TAP-PAP CS (Type II CBT) 21 (28%)

CPAP (monotherapy) 43 (57%)

Study of 75 patients who had received a Fusion Custom Mask at my Dental Sleep Center 2009-2012

Journal of Dental Sleep Medicine, In Print.

When to consider Combination Therapy

Dual Therapy:

• Unable to achieve therapeutic goals with OAT alone

• Unable to manage side effects while advancing mandible with OAT

• CPAP required but intolerant

• MD requires CPAP for patient and needs mandible stable (leakage)

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Integrated Therapy:

• OSA severe and CPAP intolerant

• CPAP pressures are high

• Significant co-morbidities

• Unable to achieve goals with Dual Therapy

• Patient preference

Rickey H.Age 40BMI 40RDI 70AHI 43PSO2 66%BPAP

26/20

“Honey…The Sleep Lab called”

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• Medical discharge from Navy

• 24 hr Oxygen• Organ failure• Polypharmacy• Too sick for surgery• BiPAP not working

We Tried Type 1 CT !

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Mandibular Advancement:11mmMaxillary Advancement: 16mm

60% Genioglossus reduction

Hope…

Ease of mind

Able to address his other issues now.

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Future of Combination TherapyType one DUAL THERAPY can be implemented today in any Dental Sleep aspect of General Practice.

Dentists and Sleep Physicians need more awareness of benefit

Need more research validation

Type two INTERGRATED THERAPY should done in a more advanced Dental Sleep Practice.

Learn and practice Establish relationship with MDMore development More research validation Profit issues

Final Considerations

• Consider Dual Therapy now for your OAT failures

• Consider learning Integrated Therapy if you desire to treat the more challenging cases

• Consider using this combination therapy to build bridges to your MD referrals

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