How to provide intraoral scans to SomnoMed for the production of SomnoDent device.

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How to provide intraoral scans to SomnoMed for the production of SomnoDent device. KEY QUESTIONS: 1. Where do I send my Case? Send intra-oral scan files (maxilla and mandible in protrusive bite) and an electronic SomnoMed Lab Form; including all fabrication instructions with return date to: eordersaustralia@somnomed.com If there are any issues, please contact your local SomnoMed Customer Service team. 2. What file type must I send? Open.stl file format 3. What file size must I select? Single arch scan is ideally 10 MB / Upper and Lower scans combined ideally total 20 MB Over 20 MB is larger than is typically required and slows the transfer speeds. Place scans in ZIP folder to compress file size, and email the ZIP folder (note: ZIP folder must be no more than 10 MB in order to email scans). 4. How do I scan my protrusive bite record? Please see Section A: Scan a SOMGauge protrusive bite record for full details. 5. What must my scan include? See the IOS Checklist and Section B-D in this document for further details 1

Contents Page: Section A - Scan a SOMGauge Protrusive Bite Record...3 Section B - Sending a SomnoDent Lab Form with your Scan...8 Section C - What must my scan include?...9 Section D - Examples of Acceptable & Unacceptable Scans...10 Section E - IOS Checklist for SomnoDent...31 2

SECTION A: SOMGauge Protrusive Bite Recording Important to note SomnoMed recommends use of the SOMGauge for accurate and repeatable bite registration scanning within the digital workflow. The SOMGauge allows precise measurement of protrusion at the same time as providing stable control of occlusal vertical opening (OVD) during recording. This is particularly useful on a patient with a heavy curve of spee, over-erupted teeth and/or anterior bite opening. A desirable protrusive bite registration is the most important process to ensuring a successful scan and as such accurate SomnoDent construction. An optimum bite record will maximise patient comfort, increase compliance and reduce chair-time. As such the SOMGauge has been designed to visually guide clinicians during bite recording to ensure a minimum 3.0mm of inter-occlusal space is maintained across the arch. This 3.0mm inter-occlusal space is the minimum dimension required at the two closest opposing teeth thereby ensuring SomnoMed can manufacture a SomnoDent appliance without needing any adjustment to OVD during manufacturing. If you are not using SomGauge: Please be aware that SomnoMed technicians require 3mm clearance between the narrowest points of contact of the two closest opposing teeth across the occlusal scheme. If you are using another bite registration technique and there is not less than 3mm clearance between two closest opposing teeth SomnoMed will contact you to open the bite. As we need to accommodate the manufacture of the SomnoDent. If we do open the vertical dimension we can use an Acculiner should you request this. Taking a protrusive bite record Please refer to our educational video on using SOMGauge. https://youtu.be/t1yn0fvs5ee Ensure fork covers some portion of last tooth! Covering some portion of last tooth ensures adequate (3.0mm) inter-occlusal clearance maintained for SomnoDent fabrication. 3.0mm 3

If a distal wrap of last tooth requested a complete coverage of last tooth by fork must be present. Complete coverage of last tooth by fork Inadequate coverage of last tooth by fork for a distal wrap case. If distal wrap ordered and inadequate coverage of last tooth by fork present the result can be an undesirable opening on virtual articulator leading to posterior premature contacts between splints requiring chairside adjustments. 4

Once bite has registration is complete trim excessive bite registration material from fork. The fork and material should be trimmed maximally as the role now of the registration is to support the lower jaw whilst occlusion scanning takes place. Trimming excess material facilitates unobstructed direct line of sight from scanner camera to teeth thereby achieving fast occlusion scanning and reduced reading errors. Step 1 Remove the bite fork from the SOMGauge. Registration material BEFORE trimming Step 2 Separate front part of fork from adjustable ramp. By removing front part of fork the operator may now freely access both left and right hand side of arch for protrusive scanning. 5

Step 3 Maximally trim all unnecessary bite material using a sharp scalpel. Unnecessary bite material is any material obscuring the buccal surfaces of the patient s clinical crowns. Where possible, expose the clear fork which will assist faster IOS protrusion scanning as camera cannot see the clear material. Step 4 Place fork in patient s mouth to check all buccal aspects of teeth are unobscured. Registration material AFTER trimming 6

If you cannot see all buccal aspects your IOS system may not be able to automatically capture desired position. If this occurs you may need to perform a manual alignment of occlusion after scanning. Obscured dentition and undesirable Unobscured dentition and fast automatic scanning Step 5 a) Scan the patients upper arch b) Scan the patients lower arch c) Scan your protrusive bite record. Place prepared SOMGauge bite registration in patient s mouth. Ask patient to gently bite and steadily hold fork between teeth to limit movement whilst scanning. Check your bite record meets SomnoMeds minimum occlusal vertical dimension requirements as per Section B. 7

SECTION B: Sending a SomnoDent Lab Form with your Scan 1) Fully complete SomnoDent Lab Form Electronic forms can be downloaded via our website https://somnomed.com/au/dental/orders-payment/ Tip! Completing SomnoDent Lab Forms online ensures most current instructions are received and reduces errors understanding handwritten notes 2) Download completed Lab Form from SomnoMed website Note: If using handwritten SomnoDent Lab Form; please scan or photograph 3) Save your completed SomnoDent Lab form as.pdf or.jpeg to your Desktop or relevant folder and email it with your intra oral scans to SomnoMed. 8

SECTION C: What must my scan include? Lab Form Also see picture examples in Section D and IOS Checklist a) Fully Completed SomnoDent Lab Form with Patient and Product Details Scan Quality b) No large holes (>0.5mm diameter) within scanned file mesh Note: Some small holes (<0.5mm diameter) are normal and acceptable c) No Unnecessary details (e.g. lips, tongue, cheeks) Note: that scans which include unnecessary details may have reduced accuracy in these areas Extensions d) Coverage of all teeth including some portion of last teeth e) Soft tissue to 5.0mm beyond gingival margin at all lingual and palatal surfaces f) Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars Occlusion g) Protrusive registration we recommend using a SOMGauge set at 60-80% of maximum protrusion Note: Should dentist require otherwise please indicate on Lab Form h) Minimum Occlusal Vertical Dimension (OVD) of 3.0mm clearance between two closest teeth in opposing arches Note: Using SOMGauge will ensure accuracy with clearance due to bite fork thickness. Optional Feature Requirements i) Distal Wrap - Soft tissue to 5mm beyond gingival margin for buccal of molars - Minimum of 3.0mm clearance between two closest teeth in opposing arches (including distal of last present teeth) j) Breathing Hole - Minimum of 5mm clearance between two closest opening anteriors k) Dentitrac Compliance Recorder - Extension of 7mm in lower posterior regions on left side l) Edentulous - Coverage of entirety of palate m) AccuLiner Articulator - Coverage of hamular notches and incisive papilla 9

Section D: EXAMPLES OF ACCEPTABLE SCANS Scan Quality Very few small data holes (<0.5mm diameter) Enough soft tissue all around No noise in scan data ACCEPTABLE: Maxilla Perfect 10

Scan Quality No data holes Enough soft tissue all around Little noise in anterior might be limited powder Little noise at terminal molar might be moving tongue Cheek or cotton roll in anterior should be avoided if possible Overall, quality is good but not perfect. A SomnoDent can be manufactured successfully using this scan. ACCEPTABLE: Mandible Good Not ideal Not ideal Not ideal 11

SCAN QUALITY Images b) No large holes (>0.5mm diameter) within scanned file mesh Some small holes (<0.5mm diameter) are normal and acceptable c) No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas ACCEPTABLE 12

SCAN QUALITY Images b) No large holes (>0.5mm diameter) within scanned file mesh Some small holes (<0.5mm diameter) are normal and acceptable c) No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas Unacceptably large hole Important area for appliance seating has unacceptable large holes UNACCEPTABLE: Holes on posterior teeth and soft tissue 13

SCAN QUALITY Images b) No large holes (>0.5mm diameter) within scanned file mesh Some small holes (<0.5mm diameter) are normal and acceptable c) No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas UNACCEPTABLE: All areas on scan must be white no red or black (3M only) 14

SCAN QUALITY Images b) No large holes (>0.5mm diameter) within scanned file mesh Some small holes (<0.5mm diameter) are normal and acceptable c) No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas NOT IDEAL: Rough regions due to repaired holes in mesh may lead to poor fits and appliance rocking. 15

SCAN QUALITY Images b) No large holes (>0.5mm diameter) within scanned file mesh Some small holes (<0.5mm diameter) are normal and acceptable c) No unnecessary details (e.g. lips, tongue, cheeks) may have reduced accuracy in these areas 15 NOT IDEAL: Cheeks included in scan reduced overall accuracy in those areas 16

Extensions Sufficient Soft Tissue Extension An Example of SomnoDent Flex In-situ Sufficient soft tissue extension ensures SomnoDent design can maximise patient comfort. 17

EXTENSIONS Images 5.0mm e) Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars 5.0mm 2.0mm f) Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars 5.0mm Include hamular notches if models need to be mounted on AccuLiner ACCEPTABLE 18

EXTENSIONS Images e) Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars f) Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars UNACCEPTABLE: Missing screw/lug housing region 19

EXTENSIONS Images Artefacts not ideal (likely due to tongue or cotton balls) - reduced scan accuracy in these areas e) Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars f) Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars Inadequate extension beyond gingival margin UNACCEPTABLE: Missing soft tissue 20

EXTENSIONS Images e) Teeth and soft tissue to 5.0mm beyond gingival margin at all lingual surfaces and buccal of molars 5.0mm f) Teeth and soft tissue to 2.0mm beyond gingival margin at facial surfaces of anteriors and premolars UNACCEPTABLE: Missing upper left posterior region 20

Occlusion Not ideal To ensure future scans are also successful: Lateral scans ideally should scan more soft tissue Lateral scans ideally should not include canines (due to curvature of jaw) ACCEPTABLE: Alignment Successful Not ideal 22

OCCLUSION Images h) Minimum of 3.0mm clearance between two closest teeth in opposing arches (include distal of last molars if Distal Wrap requested) 3.0mm ACCEPTABLE 23

OCCLUSION Images h) Minimum of 3.0mm clearance between two closest teeth in opposing arches (include distal of last molars if Distal Wrap requested) UNACCEPTABLE: Too closed (teeth in contact) 24

OCCLUSION Images h) Minimum of 3.0mm clearance between two closest teeth in opposing arches (include distal of last molars if Distal Wrap requested) 10.1mm NOT IDEAL: Too open (unless specifically requested) 25

OCCLUSION Images g) Protrusive registration set at 60-80% of maximum protrusion 60-80% ACCEPTABLE 26

OCCLUSION Images g) Protrusive registration set at 60-80% of maximum protrusion NOT IDEAL: Centric position 27

Dentitrac Requirements Breathing Hole Requirements 7.0mm 5.0mm NOTE: If requesting Compliance Recorder we require >7mm soft tissue extension beyond gingival margin at lower buccal. NOTE: If requesting Breathing hole we require a minimum 5.0mm opening between anterior teeth. 28

Sufficient Soft Tissue Extension Sufficient palatal soft tissue extension ensures SomnoMed can fabricate an appliance that is minimal in dimension and as comfortable as possible NOTE: Only for SomnoDent Edentulous design do we require a full palate 29

Distal Wrap Requirements Requesting Distal wrap requires minimum 3.0mm inter-occlusal clearance between distal of last molars. 30

IOS Checklist for SomnoDent 1. LAB FORM Image Upper Lower A Fully completed Prescription Sheet with Patient and Product Details 2. SCAN QUALITY Image Upper Lower B No large holes (>0.5mm diameter) within scanned file mesh C No unnecessary details (e.g. lips, tongue, cheeks) 3. EXTNSIONS Image Upper Lower D Coverage of all teeth including some portion of last teeth E Soft tissue to 5.0mm beyond gingival margin for all lingual and palatal surfaces 5.0mm F Soft tissue to 2.0mm beyond gingival margin for all facial surfaces of anteriors and premolars 2.0mm G Teeth and soft tissue extensions required to accommodate coupling mechanism of appliance ordered 31

4. OCCLUSION Image Upper Lower H Protrusive registration set at 60-80% of maximum protrusion OR Prescription sheet states reason for protrusion 60-80% protrusion I Minimum of 3.0mm clearance between two closest teeth in opposing arches (excluding distal of last present teeth) 3.0mm 5. OPTIONAL FEATURES Image Upper Lower J Distal Wrap Soft tissue to 5.0mm beyond gingival margin for buccal of molars K Distal Wrap Minimum of 3.0mm clearance between two closest teeth in opposing arches (including distal of last present teeth) 3.0mm 3.0mm L Breathing Hole Minimum of 5.0mm clearance between two closest opposing anteriors 5.0mm M Compliance Recorder Extension of 7.0mm in lower posterior regions on left side 7.0mm N/A N Edentulous Coverage of entirety of palette N/A O AccuLiner Articulator Coverage of hamular notches and incisive papilla 32