PROCEDURES - Phibo® · PROCEDURES BEFORE USING DEFCON® The DEFCON Tissue Care® implant system...

SURGICAL PROCEDURE

PROCEDURESBEFORE USING DEFCON®

The DEFCON Tissue Care® implant system adds to its innovative andregistered design, state-of-the-art technological features, developedexclusively for professionals that deem technology an advantage anddesign as a benefit.

DEFCON Tissue Care® meets all requirements established by Europeanlaws and guidelines regarding the manufacture and distribution of themedical-healthcare products.The healthcare products associated with this document are CE certified.The label of each individual product includes the identification numbercorresponding to the authorities notified. Impladent, S.L., meets themost rigorous international quality standards for healthcare products,ensuring perfect quality in their products and with ongoing increase incustomer satisfaction as its only goal.

The use of components or products not manufactured by Impladent,S.L,.that come into contact with DEFCON Tissue Care® implant systemoriginal components manufactured by Impladent, S.L., under originaldesign specifications, may cause severe injury to the patient, sincethose non-original components were not considered for use with theones mentioned in the documents provided by the manufacturer.

The use of non-original components or instruments indicated in thisprocedure that come into contact with the mentioned components shallautomatically render any warranty on Impladent-manufactured productsinvalid.

The use and application of DEFCON Tissue Care® dental implant systemis outside the manufacturer’s control, and the user shall be responsiblefor any damage or harm the user may cause as a result of product use.Impladent S.L disclaims any responsibility for damages derived frominappropriate handling or use.

Re-use of disposable products may damage their technical specifications,and also carries the risk of tissue infection, surgical failure, prosthodonticfailure and/or injury to the patient's health.

DEFCON Tissue Care® implant system documents are periodicallyupdated in accordance with the status of science and technology.Users of DEFCON Tissue Care® products should periodically requestinformation and should also attend regularly-held training courses onthe product and technique. The use and placement of DEFCON TissueCare® implants in unsuitable areas and the use of surgical instrumentsor prosthetic components not included in this procedure may causesevere injury to patients and total loss of the product warranty. DEFCONTissue Care® implant system is designed to perform tooth rehabilitationon a single or multiple basis according to the traditional clinical processesincluded in this document. Cases with insufficient bone for implantfixation, at risk- clinical cases, such as sinus elevations, fillings, advancedsurgical techniques, cases with non-parallelism between severe orunsuitable implants, among others, shall be excluded from warrantycoverage.

DEFCON Tissue Care® implant system is internationally distributed invarious countries with different technical and sanitary regulations andlaws, so differences in the procedure content may vary among countries.Contact an exclusive DEFCON Tissue Care® distributor in your countryand request product documents and availability.

Impladent, S.L. Reserves the right to modify and further develop theproducts inc luded in th is procedure w i thout pr io r not ice .All rights reserved. Written authorization by DEFCON Tissue Care® &Impladent, S.L. is required to reprint or process the content of thispublication in any format.

DEFCON® Implants, Tissue Care®, TSA®, TSH®, Avantblast®, ProUnic®,ProUnic Plus®, Dupllt, Softissue, International DEFCON Group®, Ific,VK, Bonetech, Genoral, Esthetic Tissue, DEFCON Esthetics, DEFCON®

Surglcal, DEFCON® Prostodontics, DEFCON® Scientific, are registeredand/or commercial brands of Impladent, S.L. DEFCON® implants areprotected by international patent. Other products and accessories areprotected by patents or have patent pending.

Illustrations for this procedure are not scaled.

TECHNICAL INFORMATION

The information detai led below is insuff icient for proper use ofDEFCON Tissue Care® dental implants. The person using them shouldhave sufficient training and information on the dental implantologicaltechnique for the use of DEFCON Tissue Care® dental implants.

See the information detailed in the implant information leaflet prior touse. Instructions for use and maintenance of DEFCON Tissue Care®

products are included in the documents and procedure manuals of theDEFCON Tissue Care® implant system.

SURGICAL PROCEDURE

I N T R O D U C T I O N

D E S I G N

M I C R O D E S I G N

M A C R O D E S I G N

P U R P O S E O F T H E I M P L A N T S

I M P L A N T D I A M E T E R

I M P L A N T C O N N E C T I O N

S E L F - T A P P I N G P R O F I L E

I N S E R T I O N S P E C I F I C A T I O N S

I N S E R T I O N A R E A S

A C C E S S O R Y O P T I O N S A C C O R D I N G T OP R O S T H O D O N T I C R E H A B I L I T A T I O N

T R E A T M E N T P L A N N I N G

M E D I C A L H I S T O R Y, C L I N I C A L D I A G N O S I SA N D E X P L O R A T I O N

S T U D Y M O D E L S

I N S T R U M E N T S A N D S U R G I C A L T R A Y

P R E P A R I N G T H E S U R G I C A L F I E L D

S T A N D A R D P R O C E S S F O R C L E A N I N G ,D I S I N F E C T I N G A N D S T E R I L I Z I N GD E F C O N ® I N S T R U M E N T S

M A N U A L C L E A N I N G

M E C H A N I C A L C L E A N I N G

D I S I N F E C T I O N

S T E R I L I Z A T I O N

S U R G I C A L S E Q U E N C E S O F I N S E R T I O N

B O N E B E D P R E P A R A T I O N

I N I T I A L S U R G I C A L S E Q U E N C E

T S H ® S E R I E S 2 F I N A L S U R G I C A L S E Q U E N C E




D E F C O N ® I M P L A N T P A C K A G E A N D L A B E L

O P E N I N G T H E P A C K A G I N G

I M P L A N T R E M O V A L F R O M B L I S T E R

I M P L A N T I N S E R T I O N

M O U N T D I S M O U N T I N G

P R O C E D U R E S W I T H D E F C O N T I S S U E C A R E ®

CONTENT:

0 2

0 3

0 4

0 7

0 9

1 0

1 0

1 2

1 8

1 9

2 0

2 1

2 2

2 3

01

02

DEFCON Tissue Care® implant system is designed to simplify and reduceclinical processes and rehabilitation time, while providing greater estheticsand patient comfort from the very beginning. Tissue care and maintenanceare its goals.

This concept, together with the TSH® implant connection standardization,offers not only rewarding results to patients from the very beginning, butit also assumes obtaining greater profits for the dental clinic, as it reducesprocesses, times and components, apart from obtaining excellent clinicalresults in the short, medium and long term.

NANODIMENSION – MICRODESIGN.

AVANTBLAST® is the DEFCON Tissue Care® implant system surface.Following the research line for implant surface treatment based on chemicalattack, AVANTBLAST®, is progress and optimization in biological responses,improving results on surfaces obtained with acid etching and laterpassivation.

The AVANTBLAST® surface, made with a double chemical attack, combineskey factors to facilitate the biological response: optimal roughness,increasing the actual implant surface; exclusive, outstanding porosity witha morphology very similar to that of bone tissue, greatly moisturizedaccording to the surface tension of the various biological repair stages;controlled thickness increase of the superficial titanium oxide layer, achievingthree times the thickness of the natural layer; and ceramic stoichiometricconfiguration, resulting in decreased metallic ion release into the environment.

All these factors achieve a better implant-bone bond, with greater retentionstrength and greater stability, optimizing the osseointegration process andattaining clinical success and rehabilitation survival.

MACRODESIGN

The TSH® implant system is designed to simplify clinical and laboratoryprocesses by means of its standardized connection. This concept ofsimplification, together with the research and development of theAVANTBLAST® surface combined with the implant’s self-tapping aims to:

Make implant insertion easier.

Achieve greater contact surface.

Create constant biomechanical stimulus.

Achieve the maximum primary stability possible as of insertion.

Reduce temperature generated during implant insertion.

Provide maximum prosthesis versatility.

INTRODUCTION

HISTOLOGICAL CUT OF BONE AND IMPLANT

SURFACE AVANTBLAST®

DESIGN

The goal of TSH® implants is the recovery of masticatory, esthetic andphonation functions, replacing lost teeth in the mandible or maxilla throughthe surgical implantation of dental implants in the remaining bone tissue,and the rehabilitation of the various functions through suitable prostheses.

IMPLANT DIAMETER

TSH® implant system consists of four self-tapping implants manufacturedin pure Titanium Grade 2.

IMPLANT SERIES 2:

Body diameter 3.3mm, internal metric 1.8mm, available in various lengths.

IMPLANT SERIES 3:


IMPLANT SERIES 4:


IMPLANT SERIES 5:


STANDARDIZED IMPLANT CONNECTION

The TSH® implant has various shoulder diameters with external hexagonthat provide the anti-tapping characteristic of the prosthetic elements fixedto the implant via retention of the prosthesis’ definite screw. Hexagonplatforms and heights for each series are:

IMPLANT SERIES 2:

Shoulder diameter 3.3mm, hexagon height 1.0mm.

IMPLANT SERIES 3:


IMPLANT SERIES 4:


IMPLANT SERIES 5:


SELF-TAPPING PROFILE

The TSH® implant is self-tapping. The main advantages of the outer threaddesign are: minimally invasive and directional to facilitate implant insertionand shorten surgical times; reduced bone temperature increase duringimplant insertion, biomechanical stimulus of the bone tissue and maximumimplant stability after its insertion.

The contra-angle bone tap and apical zone design, with the progressivenucleus of the implant shoulder, offers the great implant primary stabilitynecessary for treatment success as a result.

The excellent chewing load distribution makes stimulating bone repair andsubsequent maintenance easier.

PURPOSE OF THE IMPLANTS

EXTERNAL HEXAGON PLATFORM

BODY

3.3mm

PLATFORM

3.3mm

PLATFORM

4.0mm

BODY

3.6mm

PLATFORM

4.0mm

BODY

4.2mm

03

BODY

4.8mm

PLATFORM

5.0mm

DEFCON TSH® implants are not to be used when there are medicalcontraindications.

In general, the use of implants in the maxilla and jaw are not indicated forunitary load, when there is a discrepancy between the superficial area ofthe implant and the size of the crown to be replaced.

Insertion specifications described in this procedure for every TSH® implantseries are based on the type of dental root surface to be replaced and onthe mean size, surface, and functional chewing loads of the natural crownto be borne.

SPECIFIC INDICATIONS WITHPROPER WIDTH, HEIGHT AND BONE QUALITIES:

· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of the crown of the lateral incisors and inferior centrals.

· Indicated in the rehabilitation of total edentate patients by an overdenture supported by 4 or 6 implants in the antero-superior area and 4 implants in antero-inferior area, splinted by means of a rigid metallic structure.

Combining series 2 implants with series 3 or 4 implants depending on thebone area and the load‘s strength, bone quality and type of arch antagonistis recommended.

· Indicated when there exists a bone vestibule-lingual thickness deficiency in antero-inferior areas.

CONTRAINDICATIONS:

· 10.0mm long implants are contraindicated in bone with bone quality type III or IV for bearing a unitary crown.


· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of crown of the lateral superior incisors, inferior premolars and second superior premolars.

· Indicated in the rehabilitation of total edentate patients by an overdenture supported by 4 or 6 implants in the antero-superior area and 4 implants in antero-inferior area, splinted by means of a rigid metallic structure.

Combining series 3 implants with series 4 implants, depending on bonearea and load strength, bone quality and type of arch antagonist, isrecommended.

CONTRAINDICATIONS:


TSH® IMPLANT INSERTION SPECIFICATIONS

04

INSERTION AREAS

PLATFORM

3.3mm

IMPLANT SERIES 2.

HEXAGONHEIGHT

1.0mm

PLATFORM

4.0mm

IMPLANT SERIES 3.

HEXAGONHEIGHT

0.7mmMAXILLARY

MANDIBULAR

MANDIBULAR

MAXILLARY

IMPORTANT:

Implant insertion outside the range of these specifications can cause severe harm to patient’s health.

WARNING:

Product design, performance and treatment success arebased on the indications set forth above. All products notcomplying with the described indications or clinical caseswith insufficient bone, clinical cases involving advancedsurgery, biomaterial incorporation, sinus elevations, bonefillings, advanced surgical techniques, and lack of parallelismbetween implants, among other factors, are not underguarantee.

05


· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of the crown of the central superior incisors, canines and premolars both in jaw and maxillary.

· Indicated in the rehabilitation of total edentate patients by an overdenture supported by 4 or 6 implants in the antero-superior area and 2 or 4 implants in antero-inferior area, splinted by means of a rigid metallic structure.

· Indicated in cases of first inferior and superior molars of reduced size, series 4 implants can be used if there is no situation that contraindicates it.

CONTRAINDICATIONS:



· Indicated in fixed unitary and multiple rehabilitations by the replacement of natural roots and support of molars’ crown both in jaw and maxillary.

CONTRAINDICATIONS:


PLATFORM

4.0 mm

IMPLANT SERIES 4.

HEXAGONHEIGHT

0.7mm MAXILLARY

MANDIBULAR

PLATFORM

5.0 mm

IMPLANT SERIES 5.

HEXAGONHEIGHT

1.0mmMAXILLARY

MANDIBULAR

ACCESSORY OPTIONS ACCORDING TO PROSTHODONTIC REHABILITATION

* In the abutment section the following items should be considered:Implant/shoulder/diameter; interocclusal space; interdental space, lack ofparallelism and planned prosthodontic rehabilitation.

SCREWED

CEMENTED

SCREWED

SCREWED

UCLA HEXED CASTING CYLINDER

HEXED ABUTMENT POST

INVERTED TAPER ABUTMENT

UCLA HEXED CASTING CYLINDER

ANGLED ABUTMENTS 15º 25º WITH SCREW

BALL ABUTMENT

UCLA NON-HEXED CASTING CYLINDER

OVERDENTURES

MULTIPLE

SINGLE

06

HEXED INVERTED TAPER CASTING CYLINDER

DEFCON® TSH®. RADIOLOGICAL TEMPLATE SCALES 1:1 - 1.25:1.

07

The purpose of dental implant treatments is to restore the functionality oflost natural teeth.

The cornerstone for achieving the treatment goals is treatment planningby means of prosthodontic rehabilitation. For this purpose it is necessaryto use the clinical history, clinical-radiological diagnosis, examination, andstudy models, among other things, according to general regulations andprotocols applicable to implantology.

The following general information should be obtained in order to carry outthe treatment:

· Clinical history,

Overall: Personal and family medical history, Overall health status

Specific: Health status of mouth and teeth.

· Clinical and radiological examination.· Registering of the anatomical status through study models.· Diagnosis and treatment plan.· Patient’s expectations.· Possible contraindications.

GENERIC CONTRAINDICATIONS:

RELATIVE:

Age, stress, smoking, pregnancy, bone deficiency, alcoholism, drug abuse,lack of oral hygiene, periodontal diseases, and addictions in general,among others.

ABSOLUTE:

Endocrine (decompensated diabetes mellitus, hyperparathyroidism), blooddyscrasias for which surgical therapies are contraindicated, cardiovascularand/or end-stage conditions, infectious diseases, radiation therapy,corticotherapy and anticoagulant therapy, epilepsy and psychologicalfactors.

Data collected jointly with clinical examinations permit making a clinicaldiagnosis and the designing of the prosthodontic rehabilitation.

To confirm the initial diagnosis, impressions are made to obtain studymodels by mounting them in a semi-adjustable articulator guided by thebite record. This allows for the determination of edentate areas and thedimensions of the available space, patient’s occlusion, type of archantagonist to the area to be rehabilitated.

TREATMENT PLANNING

Reconstruction waxing is made establishing the dimensions and designof the future prosthesis. The wax-up allows for making a temporary repairand constructing surgical guides to locate implants and prosthodonticrehabilitations necessary for their insertion. DEFCON Tissue Care® systemincludes Open Guide® guides for surgical splint insertion.

An advantage of the titanium guide design is the vestibular opening, facilitatingthe access of the initial surgical drills and osteotomy visualization. (Fig.2).

Clinical, radiological and model examinations are basic tools for definingthe type of rehabilitation needed for patients to recover their anatomicalstructures, chewing function and esthetics. A treatment plan is drawn upincluding rehabilitation planning over time, type of prosthesis, number ofnecessary implants as support of the prosthesis type, and implant positionlevel in relation to bone crest and soft tissue, among other things.

Treatment planning is paramount to safeguard biological structures. Thegoals of this are: foreseeing the load along the implant transversal axis,avoiding extension elements, management of transversal loads, stabilitycontrol, occlusion and control of hygiene and parafunctions stimulatingbone anchoring with the incorporation of a number of implants of lengthand diameter that fit the anatomical situation, permitting a counterbalanceof forces acting on different levels.

TAC

FIG. 2 OPEN GUIDE® GUIDE AND SURGICAL SPLINT

08

09

The surgical tray is supplied unsterilized.

The surgical tray design offers solid ergonomics in the surgical field. Itconsists of a base, a tray where the surgical instruments are placed, anda cover.

Before surgery it is necessary to clean each and every one of thecomponents of the tray separately, paying close attention tohard-to-reach areas.

The detergents used as chemical cleaners on their own cannot eliminateall the dirt and/or waste, therefore it is essential to clean carefully by handwith an sponge or a soft cloth to remove most of the material adheredfollowing surgeries.

A clean soft bristle brush is recommended for hard-to-reach areas. Solvents,abrasive cleaners, metalic brushes or abrasive pads should not be used.

A soft, neutral pH, enzymatic detergent is recommended.

Additionally, surgical trays may be mechanically cleaned in an ultrasoniccleaner.

Prior to use, check that all surgical tray components are clean and freeof damage.

Do not introduce any instrument other than the one indicated so as to avoidoverloads or the inappropriate entry of water vapor through the holes.

It is important to make clear that surgical drills are indicated for a maximumof ten (10) uses. Their maintenance, accurate disinfection and cleaning,protection from strikes, and lack of residue deposits thereon favormaintenance and cutting specifications. Poor cleaning and maintenancedecrease drill use and cuts and may lead to the failure of the implanttreatment.

DUAL FUNCTION TORQUE WRENCH

DEFCON Tissue Care® system torque wrench has a dual function as torquecontrol and as torque wrench proper (Fig. 1).

The torque wrench is supplied unsterilized. It is important to disinfect andclean torque wrenches prior to their use. At the lower part of the torquewrench it is possible to regulate the recommended torque for implantinsertion or positioning and fastening of definitive prostheses (Fig.2).

The torque to be used is set on the torque wrench. When the torque wrenchexerts forces in relation to the established torque, it bends on the upperpart or head, indicating that the established force has been reached (Fig 3).

INSTRUMENTS AND SURGICAL TRAY

10

The preparation of the surgical field, as well as cleaning, disinfection andsterilization processes in implantology instruments, components andequipment is based on hygiene and patient safety procedures as foundin general regulations and protocols applied in dentistry practices.

Below we provide a summary detailing part of these standard protocolswith the specific indications for the DEFCON Tissue Care® implant system.

The surgical field should be under aseptic conditions before and duringthe surgical intervention.

General aspects of surgical field preparation involve such things as:

· The patient’s clinical record, technical information and treatment plan.

· Sterilized DEFCON Tissue Care® implant system instruments.

· Sterilized instruments, components and generic equipment for surgery.

· Surgical table protected by sterile drapes.

· Positioning all instruments visibly and in the order of use on the surgical table, bearing in mind surgical procedures.

· Protection of operating room equipment and components with sterile towels.

· Surgical engine with new irrigation hoses.

· Patient preparation for surgery. Mouthwash, cleaning and disinfection of the surgical area.

· The staff should be equipped with the specific surgical apparel for this purpose, such as surgical gown, mask, sterile disposable gloves, protective plastic goggles and suitable shoes, among other things. In addition they are to wash and disinfect their arms and hands according to the standard protocol.

It is important to mention that during the surgery a sterile package withnormal saline should be available for the placement of the instrumentsused, such as surgical drills, scalpel blades, torque wrenches, adapters,etc., in order to avoid strikes and deposits on the instrument surface.

STANDARD PROCESS FOR CLEANING, DISINFECTING ANDSTERILIZING DEFCON® INSTRUMENTS

Cleaning, disinfection and sterilization processes, as well as surgical fieldpreparation, are based on the hygiene and patient safety procedures setforth in general standards and protocols applied in dentistry practices.

Below we provide a summary detailing part of these standard protocols withthe specific indications applicable to them from the DEFCON Tissue Care®

implant system.

PREPARING THE SURGICAL FIELD

11

The usual cleaning, disinfection and sterilization process begins by removingthe instruments from the package with normal saline used during thesurgery.

MANUAL CLEANING

Following that, instruments should be carefully cleaned of any organicremains prior to their disinfection and sterilization. Cleaning is preferablydone with a white bristle brush and plenty of water throughout the processin order to eliminate any organic remains deposited on the instrumentsurface.

MECHANICAL CLEANING

Once manual cleaning is complete, mechanical cleaning will be carriedout with ultrasonic cleaner for the detachment of hard-to-see or hard-to-reach particles.

It is important to use descaling products or detergents specific for thisprocess, strictly following the manufacturer’s instructions for use withrespect to time, temperature and concentrations.

DISINFECTION

Disinfection should be cold disinfection, in a container with specific productsfor said purpose.

Do not use peroxide, strong acids or products with high chlorine content;only products whose pH is between 5 and 9 are appropriate. Manufacturer’sinstructions for use with respect to time, temperature and concentrationsshould be strictly followed.

IMPORTANT:

Failure to comply with the indications given by manufacturers of theproducts used in the procedures described above can lead to seriousdamage to material, such as instrument rusting, loss of surgical drillsharpness and life-span; in addition, there are complications in thesubsequent surgery, producing bone overheating/necrosis and lack ofimplant osteointegration.

STERILIZATION

Sterilization is carried out by autoclave in an ordinary sterilization cycle ata maximum of 135º C for a minimum of 6 minutes. Dry heat sterilizersshould not be used since they would directly affect sharpness and otherfeatures of surgical instruments. Do not remove the material from theautoclave before the drying cycle is complete.

PREPARACIÓN DEL LECHO ÓSEO

TSH® implant is designed to be placed at bone crest level. Implant lengthis defined as the distance from the maximum shoulder diameter to theimplant apex or base (Fig. 1).

Bone bed preparation is carried out with an initial surgical sequencecommon to all series and a final surgical sequence specific for eachimplant series.

During surgical preparation of the implant bone bed, the following shouldbe kept in mind:

· Use plenty of external refrigeration with sterile water solution or NaCl solution, pre-cooled at 5º C.

· Apply soft and intermittent pressure to the bone.

CONSIDERATIONS

During the preparation of full length bone beds in all implant diameters,apply minimum pressure at the end of the preparation, increasing theintervals between these and removing the bit from within the duct beingprepared in order to allow for bleeding, decrease of local pressure andcooling, thus avoiding bone overheating and necrosis.

It is important to remove drilling residues by means of irrigation with syringeand sterile solution at the end of the surgical sequence.

Surgical drills are indicated for a maximum of 10 uses. Exceeding thenumber of indicated uses affects the success of the implantologicaltreatment.

Recommended turning speeds for drilling, depending on drill diameter,are specified in the attached chart.

LENGHT 13.0mm

CRESTAL INSERTION

* BONE CREST LEVEL

* 0.7mm

IMPLANT LENGHT

13

.0m

m

16.0mm14.5mm13.0mm11.5mm

10.0mm

8.5mm

7.0mm

12

850

850

850

750

750

650

550

350

ROUND MARKING BURS1.8mm

ROUND MARKING BURS2.3mm

INITIAL HELICAL DRILL2.3mm

2.8mm

TSH® SERIES 3 FINAL HELICAL DRILL3.0mm

TSH® SERIES 4 FINAL HELICAL DRILL3.6mm

4.1mm TSH® SERIES 5 FINAL HELICAL DRILL

Ser ies

850PRECISION DRILL

DESCRIPTION RPMDIAMETER

R E C O M M E N D E D T U R N I N G S P E E D S

SURGICAL CRESTAL DRILL

TSH® SERIES 2 FINAL HELICAL DRILL

FIG.1

IMPORTANT, PRIOR TO INSERTION.

The preparation of the bone bed requires the use of special, sharpinstruments under constant irrigation, with completion of the specificsurgical sequence for the insertion of each implant indicated in that surgicalprocedure and with the speeds recommended therein. Failure to do somay result in the use of excessive force in implant insertion (greater than50Ncm), exceeding bone resistance, causing damage to the implant andits connection, cold welding of the implant with the mount, implant fracture,necrosis and bone fracture,among other things.

IMPLANT INSERTION

Ø1.8mm850 rpm

FIG.1

Ø2.3mm850 rpm

FIG.2

850 rpm

FIG.3

FIG.4 FIG.5

DENTAL FLOSS

Ø2.3mm

Ø2.3mm

850 rpm

13

ROUND MARKING BURS

PRECISION DRILL

INITIAL SURGICAL SEQUENCE

Once the incision is made, the flap lifted and the bone crest uncovered,the surgical splint is positioned with the Open Guide® guides alreadyincorporated to the splint, making the drilling and the direction of thevestibulo - palatino/lingual axis easier. In the cases of narrow bonecrests, their regularization is recommended to increase the vestibulo-lingual/palatine width, leaving enough bone margin following placementof the implant.

INITIAL SURGICAL SEQUENCE / ROUND MARKING BUR.

The initial sequence begins with a Ø1.8mm round marking bur, with aturning speed of 850rpm, inserting through the surgical splint guideand marking the bone crest (Fig.1).

After marking with the Ø1.8mm round marking bur, a Ø2.3mm roundmarking bur at a turning speed of 850 rpm is used to mark and increasethe diameter in the bone crest, centralizing the axis for the nextosteotomy (Fig.2).

It is deepened with the Ø2.3mm round marking bur, piercing the cortical bone.

INITIAL SURGICAL SEQUENCE / PRECISION DRILL.

The initial sequence begins with an Ø2.3mm precision drill, with aturning speed of 850 rpm, inserting it through the surgical splint guidesurpassing the cortical bone and centralizing the axis for the nextosteotomy. (F ig.3) .

After that, the Ø2.3mm helical drill is used at a turning speed of 850 rpm untilthe programmed length is attained, exerting mild and intermittent pressure.

The use of a precision drill is recommended in clinical cases where thediagnosis permits surgery without l i f t ing the soft t issue f lap.

DRILLING LENGTH

Once the cortical bone is passed, the initial Ø2.3mm helical drill is usedat a turning speed of 850 rpm until the programmed length is attained,exerting a mild and intermittent pressure, with the purpose of avoidingbone overheating (Fig.4).

Following that, the depth indicator drill/parallelizer is inserted to checkdrilling length and parallelism; at this point corrections may be madefor the next.(Fig.5).

IMPORTANT:

Abundant irrigation is necessary in all osteotomies and procedures untilimplant insertion.

*All helical drills in the DEFCON Tissue Care® system are available in twomeasures, short and long, depending on the available space and insertionareas, except for helical drills in Series 5, designed in one length only.

Ø2.8mm

750 rpm

FIG.6

DENTAL FLOSS

Ø2.8mm

FIG.7

14

CONTRA-ANGLE BONE TAP

BONE QUALITY TYPE I AND II

FIG.8

15 rpm

Once the initial sequence is completed for all series, the final osteotomysequence begins for the TSH® Series 2 implant. The diameters of theshoulder, body and the remaining TSH® implant specifications are describedat the beginning of this procedure.

The final osteotomy for TSH® Series 2 implant is made with Ø2.8mm helicaldrill at a turning speed of 750 rpm until the programmed length, exertingmild and intermittent pressure (Fig6). The Series 2 Ø2.8mm depth indicatordrill is inserted to check whether the total length drilled corresponds tothe programmed drilling length (Fig.7). Passing dental floss through thedepth indicator orifice is recommended to avoid that the indicator isswallowed by the patient.

In case of bone quality type I or II, in thick cortical and anterior maxillaryand mandibular regions, tap threading of the implant in the bone bed iscarried out with the Series 2 contra-angle bone tap at a turning speed of15 rpm in the case of contra-angle (Fig. 8).

IMPORTANT:

Abundant irrigation is necessary in all osteotomies and proceduresuntil implant insertion is achieved.

TSH® SERIE 2 FINAL SURGICAL SEQUENCE

* The helicoidal drills of the DEFCON Tissue Care® system are availablein two lengths, short and long, depending on the available space andinsertion areas, except the helicoidal drills for Series 5, designed in onlyone length.

Ø3.0mm

750 rpm

FIG. 9

Ø3.0mm

FIG. 10

DENTAL FLOSS



FIG.11

15 rpm

15

Once the final surgical sequence of Series 2 is completed, the final surgicalsequence for Series 3 TSH® implant is started. Shoulder diameters, bodyand other TSH® implant specifications are determined at the beginning ofthis procedure.

The final osteotomy for TSH® Series 3 implant is made with Ø3.0mm helicaldrill at a turning speed of 750 rpm until the programmed length, exertingmild and intermittent pressure (Fig.9). The Series 3 Ø3.0mm depth indicatordrill is inserted to check whether the total length drilled corresponds tothe programmed drilling length (Fig.10). Passing dental floss through thedepth indicator orifice is recommended to avoid that the indicator isswallowed by the patient.

In case of bone quality type I or II, in thick cortical and anterior maxillaryand mandibular regions, tap threading of the implant in the bone bed iscarried out with the Series 3 contra-angle bone tap at a turning speed of15 rpm in the case of contra-angle (Fig. 11).

IMPORTANT:

Abundant irrigation is necessary in all osteotomies and proceduresuntil implant insertion is achieved.

TSH® SERIE 3 FINAL SURGICAL SEQUENCE

* The helicoidal drills of the DEFCON Tissue Care® system are availablein two lengths, short and long, depending on the available space andinsertion areas, except the helicoidal drills for Series 5, designed in onlyone length.

16

FIG.12

Ø3.6mm

650 rpm

Ø3.6mm

DENTAL FLOSS

FIG.13



15 rpm

FIG. 14

* Every helicoidal drill of the DEFCON Tissue Care® system is available intwo lengths, short and long, depending on the available space and insertionareas, except for the helicoidal drills for Series 5, designed in only onelength.

TSH® SERIES 4 FINAL SURGICAL SEQUENCE

Once the final surgical sequence of Series 3 is completed, the final surgicalsequence for Series 4 TSH® implant is started. Shoulder diameters, bodyand other TSH® implant specifications are determined at the beginning ofthis procedure.

The final osteotomy for TSH® Series 4 implant is made with Ø3.6mm helicaldrill at a turning speed of 650 rpm to the programmed length, exertingmild and intermittent pressure (Fig.12). The Series 4 Ø3.6mm depthindicator drill is inserted to check whether the total length drilled correspondsto the programmed drilling length (Fig. 13). Passing dental floss throughthe depth indicator orifice is recommended to avoid that the indicator isswallowed by the patient.

In case of bone quality type I or II, in thick cortical, maxillary and mandibularregions, tap threading of the implant in the bone bed is carried out withthe contra-angle bone tap of Series 4 at a turning speed of 15 rpm in thecase of contra-angle use (Fig 14).

IMPORTANT:


FIG.16

DENTAL FLOSS

Ø4.1mm

FIG. 17



15 rpm

FIG. 15

Ø4.1mm

550 rpm

17

Once the final surgical sequence of Series 4 is completed, the final surgicalsequence for TSH® implant of Series 5 is begun. Shoulder diameters,body and other TSH® implant specifications are determined at the outsetof this procedure.

The final osteotomy for TSH® Series 5 implant is made with Ø4.1 mmhelical drill at a turning speed of 550 rpm to the programmed length,exerting mild and intermittent pressure. (Fig. 15). The Series 5 Ø4.1 mmdepth indicator drill is inserted to check whether the total length drilledcorresponds to the programmed drilling length (Fig. 16). Passing dentalfloss through the depth indicator orifice is recommended to avoid thatthe indicator is swallowed by the patient.

In case of bone quality type I or II, in thick cortical, maxillary and mandibularregions, tap threading of the implant in the bone bed is carried out withthe contra-angle bone tap of Series 5 at a turning speed of 15 rpm in thecase of contra-angle use (Fig 17).

IMPORTANT:


* Series 5 helicoidal drills of the DEFCON Tissue Care® system areavailable in only one length.

TSH® SERIES 5 FINAL SURGICAL SEQUENCE

18

Implant Implante Impianto

Implantat Implante

PRESS

3.6

SYMBOLS FOR LABELLING CODES

IMPORTANT:

The purpose of the ID labels on each implant is to ensure the traceabilityand warranty of the product used in each patient. Place labels on: patient’shistory and record; laboratory fact sheet related to the clinic and patient;finally, place label on any procedure that should be identified in relationwith the patient’s treatment.

DOUBLE BLISTER PACKAGING

DEFCON TISSUE CARE® IMPLANTS ARE PACKAGED BY UNIT.

IMPLANT PACKAGING

DEFCON® IMPLANT PACKAGE AND LABEL

See instruct ions for use.

Do not reuse.

Expirat ion date

Caut ion,

see attached documents.

Product lot Nº

Radiat ion ster i l izat ion

Product reference

Three adhesive labels to p lace on the

pat ien t 's fac t sheet , fo r ma in ta in ing

traceabi l i ty and guarantees.

19

FIG. 5

FIG. 4

FIG. 2

FIG. 1

FIG. 3

Prior to opening the packaging, perform a visual check to ensure thereis no damage and that the pack is not broken, torn or otherwise damaged.Moreover, before opening, check that the data included in the implant’slabel correspond to the programmed diameter and length. The expirationdate should also be checked prior to opening the container. Implants areprovided sterile via use of 25Kgy Gamma radiation.

DEFCON Tissue Care® system implants are packaged by unit.

Implant packaging is characterized by:

· Outer cardboard box for each implant series.

. ID label, including a triple adhesive label for traceability and warranty preservation.

· Package insert inside the cardboard box.

· Double blister package, sealed with Tyvek, ensuring implant sterility. (Fig.1).

· Outer blister packagig. This contains the inner packaging. Uponopening, the inner packaging should be placed in the surgical field topreserve sterility. (Fig.2).

· Inner blister packaging. It contains the implant with its mount and thelocking screw. (Fig. 3).

To open the outer cardboard box, press the spot labeled “Press” on thedie-cutting area to release the double blister packaging and the packaginginsert.

Once the external cardboard box is opened, it is important to see theindications printed on the Tyvek (Fig.1) to correctly open the external blister.When handling the outer box and opening the inner packaging, care shouldbe taken to avoid sterile field contamination; therefore, staff outside thesurgical field should handle these elements in order to maintain asepsisand sterility.

The internal container should be opened carefully, after the final osteotomy,following the indications printed on the Tyvek, and placing the containerin the surgical field (Fig. 3). A quick or excessively forceful opening of thetyvek may cause the uncontrolled release of the locking screw from theblister.

ATTENTION:

If the planned surgery is ultimately not performed due to reasons beyondyour control, the internal blister that carries the implant cannot be stored,kept or used for another surgery. The internal blister does not maintainimplant sterility.

Implant sterility is guaranteed before the external blister is opened. Theinner blister does not maintain the necessary conditions to preserve sterility.

Open the internal blister in the surgical field, immediately thereafter takethe implant out of its place and, subsequently, remove the closing screw.(Figs.4 and 5).

Implant fixation in the internal blister is done by friction between themounter and the area of the blister designed for that purpose (Fig.4). Itis important to properly place the adaptors to the mounter and ensurethat they are correctly fixed in order to move on to completely safe implantremoval and transportation to the bone bed. If the implant is dropped andsterility is compromised, the handling, cleaning, sterilization and use ofsaid implant on the patient is absolutely forbidden.

OPENING THE PACKAGING

OPENING OUTER BLISTER

OPENING INNER BLISTER IN THE SURGICAL FIELD

INNER BLISTER CONTAINING THE IMPLANT AND THE LOCKING SCREW.

FIG. 1 FIG. 2

FIG. 3

FIG. 4

20

IMPORTANT:

Prior to removing the implant from the blister and inserting it into the bonebed, the contra-angle torque and torque wrench should be adjusted to amaximum pair of 35 Ncm.

Manual or mechanical implant insertion should not exceed 35 Ncm torque;if this force is exceeded, it may cause significant or irreversible damageto the implant and on patient’s health.

The signs of excessive force when inserting an implant and the usualassociated consequences include:

· Increased mount screw-to-mount fixation.

· Excessive mount torsion leading to a cold welding between mount and implant.

· Breaking of the mount screw or implant hexagon.

· Noticeable or unnoticeable damage to the implant connection, leading to short- or mid-term post-rehabilitation implant fractures or incomplete adjustment of prosthesis to implant connection.

· Damage to the inner implant tap, leading to faults in the definite prosthesis screws, screw breaking or loss of inner implant tap.

Potential causes:

· Final osteotomy sequence using a surgical drill with a diameter below indicated size.

· Final drilling sequence and implant insertion in type I and II bone quality, without performing the tap shaping process using the contra-angle bone tap, or implant shoulder shaping process in cases of crestal implant insertion.

· Defective cut of the surgical drills, among others.

I M P L A N T M E C H A N I C A L E X T R A C T I O N F R O M B L I S T E R

Once the mechanical adaptor is connected to the contra-angle (Fig.1), themounter is inserted (Fig.2) until a slight friction and a click are noted whenthe adaptor is connected. (Fig.3).

Firmly grab the blister and set the contra-angle going at a turning speedof 15 rpm. Next, gently perform the extraction movement, separating theimplant from the blister. (Fig.4).

IMPLANT MANUAL EXTRACTION FROM BLISTER

After connecting the manual adapter to the torque wrench, it is insertedin the mount until a slight friction and a click are noticed when the adapteris connected.

Gripping firmly, take the blister and gently perform the extraction movement,separating the implant from the blister.

IMPLANT REMOVAL FROM BLISTER

CLICK RETENTION AREA

EXAMPLE OF MECHANICAL EXTRACTION

21

FIG. 1

FIG. 2

35 Ncm

15 rpm

35 Ncm

IMPLANT INSERTION

GENERAL CONSIDERATIONS

With bone quality type I and II, it is necessary to make some intermittentshort stops during the implant insertion, especially when inserting implantsof greater length and diameter. Irrigation will continue throughout theinsertion.

Once the final drilling sequence is completed, it is necessary to check thatbleeding is not excessive and to check bone bed vascularization, as wellas to confirm that there is no sharp bone projection that may interfere withimplant insertion or with subsequent soft tissue handling.

Before inserting the implant and after the final drilling sequence, it isimportant to check that the length matches the planned length using adepth indicator and to confirm that the bone bed is free of any drillingdebris.

PRIMARY STABILITY

Various factors such as bone charcateristics, bone quantity and quality,implant location and preparation technique, among others, will directlyaffect the degree of stability.

MECHANICAL AND MANUAL INSERTION

In the case of mechanical insertion, a partial implant insertion isrecommended (Fig.1), and then manual completion of the insertion usingthe torque wrench to position the implant at the desired length for a moredirect appreciation of implant primary stability. (Fig.2).

It is important to proceed with implant insertion slowly, maintainingcontinuous irrigation during insertion, with a maximum insertion torque of35 Ncm and a turning speed of 15 rpm.

During implant insertion, the recommended forces should not be exceeded;no sudden moves should be made during insertion, and the instrumentsshould always be aligned with the bone bed axis to avoid inappropriateforce or tension on the mount and implant.

EXAMPLE OF MECHANICAL INSERTION

22

*

FIG. 1

FIG. 2

FIG. 3

FIG. 4

FIG. 5

MOUNT DISMOUNTING

Once the implant is inserted, it is necessary to use the open-end wrenchfor the mount in order to minimize implant movement and maintainmaximum stability during the removal of the mount retentive screw(Fig. 1).

After positioning the open-end wrench, the manual or contra-angle hexdriver is inserted in the retentive screw (Fig. 2). Retentive screw removalis carried out in a counterclockwise fashion (Fig. 3).

The mounters’ retentive screws are calibrated with a specifc torque, tobe removed manually or mechanically without problems. Retentive screwsstay in the hex driver by friction.

In those cases where forces are superior to those indicated above, it ispossible that the retentive screw is more significantly fixed to the mounterand that the mounter becomes slightly blocked with the implant becauseof these elements’ friction and torque. In retentive screw extractionoperations and later mounter extraction operations, the use of the openend wrench is recommended, making small counterclockwise movementsin order to unblock the components (Fig.4).

Next, the mounter is removed by means of “mosquito” pliers (Fig.5).

Then, and depending on the planned treatment, surgery is completedusing the chosen procedure (see next page), after cleaning the area andthe implant using normal saline, and removing particles and debris fromthe osteotomy that may interfere with the collocation of the componentsand accessories.

* Possibilty of screw extraction with the mechanical hex driver andmanual extraction with torque wrench.

23

To complete the surgery, and depending on the planned treatment, theDEFCON Tissue Care® implant system includes different methods.

It is necessary to check the prosthodontic procedures of the DEFCONTissue Care® system in order to have complete and updated informationregarding the procedures to be applied in the planned treatment . Thedifferent options for finishing surgery are:

ONE-STAGE SURGERY

This procedure is indicated for mid-to-high bone density and quality, withcompromise of implant primary and secondary stability with respect tothe type of rehabilitation planned.

The minimum recommended waiting periods and times prior to rehabilitationare 6-8 weeks. The advantages of this procedure are:

· Minimal soft tissue manipulation, preserving the epithelial adhesionstructure, with no subsequent manipulation of the abutments.

· Improved esthetic results for the patient during waiting periods.

· Simple and quick procedures.

· Reduction in the number of clinical procedures and rehabilitation time compared with two-stage surgery.

The implant shoulder stays in contact with the oral medium during boneand soft tissue repair stages by means of the healing abutment, aroundwhich the suture is made.

TWO-STAGE SURGERY. DELAYED FUNCTION.

This procedure is indicated for clinical cases in which any kind of force orload transfer to the implant must be avoided and when there is low corticaland trabecular bone density and quality, which compromises implantstability in terms of the planned rehabilitation type.

The minimum recommended waiting periods and times prior to rehabilitationare 12-24 weeks.

The implant shoulder and the closing screw are covered by soft tissuewithout coming into contact with the oral medium.

In a second stage, the soft tissue that surrounds the healing abutmentwill be modeled.

PROCEDURES WITH DEFCON TISSUE CARE®

24

PROCEDURE CONSIDERATIONS

The abovementioned procedures are recommended under optimal clinicalsituations and with optimal bone status.

The mean time for implant osseointegration mentioned for each procedurevaries depending on factors such as insufficient bone, clinical casesrequiring complicated surgeries and techniques, biomaterial application,sinus elevation, bone filling, lack of parallelism between implants, in additionto the implant diameter and length, insertion area, planned prosthodonticrehabilitation, margin height and tissue, cortical space, interdental distanceand esthetic compromise, among others.

MAINTENANCE AND POST-OPERATIVE CONTROL

After the surgery, it is recommended that one administer ice bags to thepatient and establish an antibiotic regimen with different agents and anoral hygiene protocol.

It is important to perform post-operative follow-up and control, withradiological assessment and regular check-ups based on general regulationsand protocols applicable to implantology.

Surgical and prosthetic procedures are available from our website or yourdistributor.

This leaflet was revised and approved in 2010-03-22.

Nº REF.: PROCEQUIRTSHEN_rev4

Date post:	30-Jan-2020
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