surgical and prosthetic manual · implant surgery site preparation system implant 3.5mm ¯ x 10 mm...

SURGICAL AND PROSTHETIC

MANUAL

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This handbook is conceived for clinicians who have already attended theoretical and practical courses of implant surgery. Each clinician must be aware that continuous education is vital step to ensure updated skills and notions regarding both surgical and of prosthetic procedures.

SURGICAL PLAN

IMPLANT SURGERY TRAY

SURGICAL COMPONENTS AND DRILLS SEQUENCE

IMPLANT PLACEMENT PROCEDURE

DECONTAMINATION AND STERILIZATION PROCEDURE

Our mission is to simplify and optimize clinical activity.

CLC CONIC was ideated with limited components and ad hoc biological and mechanical characteristics, nevertheless ensuring optimal result in terms of biological, aestetic, functional outcome, even in complicated treatment plans.

CLC Conic Implant System.

• Maintenance of marginal bone.• Reduced necessity of Surgical

Regenerative therapy.• One universal platform for five

different implant diameters. • Suitable for one stage and two

stage implant procedure.• Suitable for both immediate

and early loading.

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Preoperative Planning

To perform a correct diagnosis and treatment plan it is fundamental to:

Absolute contraindications:

• Cardiac diseases, unless otherwise specified by a cardiologist.• Coagulation disorders.• Oral anticoagulants.• Psychological Diseases.• Uncontrolled acute infections.• Uncontrolled Diabetes.

Risk Factors:

• Age• Controled diabetes.• Previous radiotherapy of the jaws.• Chemotherapy.• Smoke.• Alcool and drugs consumption.• Some oral lesions.• Long lasting and High dosage corticosteroid therapy.• History of bisphosphonates assumption.

1) Obtain exhaustive medical history and clinical overview of the patient;

It is fundamental to discuss the goal of treatment with the patient, in terms of aesthetic and functional outcomes, in order to fulfill patient’s expectations.Give the patient exhaustive pieces of information regarding risks, costs and duration of treatment.

Length and diameter have to be chosen according to bone quantity. Intraoral x-rays, panoramic x-ray, diagnostic casts and clinical examination are essential steps to assess the existence of sufficient bone volume in the implant site.A deepened overview of bone anatomy can be achieved thanks to CT scans, in order to avoid iatrogenic damages caused by incorrect positioning of the implants. (i.e. inferior alveolar nerve proximity).

2) Recognition of specific oral problem;

3) Choice of implant;

Inferior alveolar nerve and mental foramen must be preserved during surgical procedures.

Submandibular fossa and space, hosting sublignual artery, must be preserved during surgical procedure.

Maxillary sinus and floor of the nasal cavity must be identified not to be penetrated during surgery.

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Implant Surgical Tray

Ø 2,0LCDR01D

Ø 3,3TDCL3316D

Ø 4,0CODR04D

Ø 3,8TDCL3816D

Ø 2,0 - 2,8PDCL28D

Ø 5,0CSCL5D

Ø 3,8 - 4,2PDCL42D

Ø 2,0TDCL216D

Ø 4,2TDCL4216D

Ø 4,0CSCL4D

Ø 2,8 -3,3PDCL33D

Ø 6,0CSCL6D

Ø 4,2 - 5,2PDCL52D

Ø 2,8TDCL2816D

Ø 5,2TDCL5216D

Ø 4,5CSCL45D

Ø 3,3 - 3,8PDCL38D

Ø 3,6TDCL3616D

Ø 4,0TDCL416D

Ø 4,5TDCL4516D

Ø 5,5TDCL5516D

shortDRCL13S

longDRCL13L

longMNCL13L

shortDRCLS

shortMNCLS

25-55 nCRIC02

mediumDRCLM

mediumMNCLM

ADDRCO longDRCLL

longMNCLL

ESCL01ø 2,0-2,8 mmPRCL01

ø 3,3-3,8 mmPRCL02

MPCL01EDCL01 mediumDRCL13M

mediumMNCL13M

shortMNCL13S

Ø 3,5CSCL35D

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Direction Drill

Sharp and resistant, they allow easy and precise surgical access even in case of thick compact bone. Moreover, it allows modification of osteothomy’s direction.

Marker drills

They are used to cut cortical bone and design the correct position of the implant.

Twist Drills for standard bone

They allow to achieve proper osteotomy’s diameter at the desired depth. Cylindrical shape are furnished with three blades that allow a balanced rotation during bone asportation. All drills are marked with depth grooves, identification batch and dimension indicator.

Drills

Twist Drill

Ø 2,0 mm TDCL216D

Ø 2,8 mm TDCL2816D

Ø 3,3 mm TDCL3316D

Ø 3,8 mm TDCL3816D

Ø 4,2 mm TDCL4216D

Ø 5,2 mm TDCL5216D

Pilot Drill

Ø 2,0-2,8 mm PDCL28D





Conturesink

Ø 3,5 mm CSCL35D

Ø 4,0 mm CSCL4D

Ø 4,5 mm CSCL45D

Ø 5,0 mm CSCL5D

Ø 6,0 mm CSCL6D

Twist Drill D1 Bone

Ø 3,3 mm TDCL3316D

Ø 3,6 mm TDCL3616D

Ø 4,0 mm TDCL416D

Ø 4,5 mm TDCL4516D

Ø 5,5 mm TDCL5516D

Twist Drill D1 Bone

Ø 3,6 mm TDCL3616D

Ø 4,0 mm TDCL416D

Ø 4,5 mm TDCL4516D

Ø 5,5 mm TDCL5516D

Marker Drill Ø 4,0 mm CODR04D

Direction Drill Ø 2,0 mm LCDR01D

Ø 2,0

Ø 2,0

Ø 4,0

Ø 3,3Ø 2,8 Ø 3,8 Ø 4,2 Ø 5,2

Pilot drills

Guide and direct the subsequent cylindric twist drill.

Cylindric Twist Drills for compact bone

They are used to increase bone preparation in the presence of compact bone.

Ø 2,0 - 2,8

Ø 3,5

Ø 3,3 - 3,8

Ø 4,5

Ø 2,8 -3,3

Ø 4,0

Ø 3,8 - 4,2

Ø 5,0

Ø 4,2 - 5,2

Ø 6,0

Cortical Drills

They are support drills that prepare the cortical bone to the correct implant diameter. They are used when compact bone is present.

Ø 3,3 Ø 3,6 Ø 4,5Ø 4,0 Ø 5,5

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H 14 mm

H 12 mm

H 10 mm

H 8 mmH 6 mm

Twist drills

Grooves indicate a progressive depth corresponding to 8,10,12,14mm, whereas the tip of the drill accounts for 0.5mm.

Please note! Grooves do not correspond exactly to the length of the drill since the tip will penetrate in the implant site with an increased measure of 0,5mm. The grooves indicate the suitable depth for implants of different lengths at the bone level.

All drills work clockwise. Each drill can be used to prepare an implant site almost 30 times, although this can slightly vary depending on the density of bone. It is mandatory to replace drills when not sharp anymore or when they are damaged.

0,5 mm

L 08 mm IMCCO358

L 10 mm IMCCO3510

L 12 mm IMCCO3512

L 14 mm IMCCO3514

L 08 mm IMCCO48

L 10 mm IMCCO410

L 12 mm IMCCO412

L 14 mm IMCCO414

L 08 mm IMCCO458

L 10 mm IMCCO4510

L 12 mm IMCCO4512

L 14 mm IMCCO4514

L 08 mm IMCCO58

L 10 mm IMCCO510

L 12 mm IMCCO512

L 14 mm IMCCO514

L 08 mm IMCCO68

L 10 mm IMCCO610

L 12 mm IMCCO612

L 14 mm IMCCO614

Standard drilling protocol Dense bone drilling protocol

Implant 3,5

Implant 4,0

Implant 4,5

Implant 5,0

Implant 6,0

Drilling Sequence guidelines

Optional pilot drill 2,8

Conturesink 3,5


Conturesink 4,0


Conturesink 4,5


Conturesink 5,0


Conturesink 6,0










Twist drill 4,2

Twist drill 4,2

Twist drill 2,0

Twist drill 2,0

Twist drill 2,0

Twist drill 2,0

Twist drill 2,0

Twist drill 3,3

Twist drill 3,3

Twist drill 3,3

Twist drill 3,3

Twist drill 2,8

Twist drill 3,1

Twist drill 2,8

Twist drill 3,6

Twist drill 2,8

Twist drill 4,0

Twist drill 2,8

Twist drill 4,5

Twist drill 2,8

Twist drill 5,5

Twist drill 3,8

Twist drill 3,8

Twist drill 3,8


Twist drill 5,2

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H 8 mmH 10 mm

H 12 mmH 14 mm

0,5 mm

H 8 mmH 6 mm

Drill stops

Drill stops

Drill stops are given in a box conceived for an easy and safe handling by the clinician.All components are manufactured with autoclavable materials, including the box.

Drill stops for Ø 2.0 and 2.8 twist drill



Ø 2,0

Ø 3,3 Ø 3,8

Ø 4,8Ø 4,0

h 8 mm STH28-CO

h 8 mm STH338-CO

h 8 mm STH428-CO

h 6 mm STH26-CO

h 6 mm STH336-CO

h 6 mm STH426-CO

h 10 mm STH210-CO

h 10 mm STH3310-CO

h 10 mm STH4210-CO

h 12 mm STH212-CO

h 12 mm STH3312-CO

h 12 mm STH4212-CO

h 14 mm STH214-CO

h 14 mm STH3314-CO

h 14 mm STH4214-CO

Ø 2,8

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Implants

Ø 3,5

H 8,0 H 6,0 H 12,0 H 10,0 H 14,0

Ø 4,5

Ø 5,0

Ø 6,0

IMCCO358

IMCCO48

IMCCO458IMCCO456

IMCCO58IMCCO56

IMCCO68IMCCO66

IMCCO3510

IMCCO410

IMCCO4510

IMCCO510

IMCCO610

IMCCO3512

IMCCO412

IMCCO4512

IMCCO512

IMCCO612

IMCCO3514

IMCCO414

IMCCO4514

IMCCO514

IMCCO614

Ø 4,0

Packaging

The CLC CONIC dental implants are provided in a sealed sterile double packaging that protects from external influences and ensure sterility during until using or expiration date.The sterile packaging complies with the European standard EN 556 - I: 2002.

The package consists of:- Rigid box (outer box) - Blister (secondary packaging) - PMMA vial with cap (primary packaging).

The implant Inside the PMMA ampoule is supported apically by a Grade 4 titanium base. The top of the collar is hold in a vertical position by a Grade 4 Titanium ring. The contact surface between the fixture and the supports is at the most reduced to guarantee the implant roughness surface integrity.

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Implant surgery

Site Preparation System Implant 3.5mm ¯ x 10 mm lenght

Ball shaped guide drill

To mark the center of the tooth to be replaced and assess bone quality.

Position markers drill

To verify the position the implant between the bone edge and adjacent teeth or implants.

Direction drill

Simplifies the achievement of a correct implant axial direction. Allows to modify the axial direction when required.

Twist drill 2.2 mm diameter

Allows to reach the desired depth (based on the marks on the drill). It will be used with a movement back and forth, keeping pression on bone for 1-2 sec. A 2.2 mm diameter direction indicator, is inserted into the initial preparation to verify the correct position and direction. In case of multiple p.

Speed 800-1200 RPM 25-30 Ncm torque and with abundant irrigation.

Surgical procedures

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Implant surgery

Implant pick up

Once the implant bone site is prepared, open the sterile blister, carefully unscrews the vial cap, engages the handpiece mounted implant driver at the implant. At this time the implant can be easily removed from vial. This kind of connection allows a safe transport and a controlled implant installation, and permits to transfer the necessary torque during the implant placement (Max torque 60 N).

Step 1

To access to the PMMA vial, break the blister squeezing out the half shell containing the vial.

Step 2

To access to the implant remove the cap of the vial. Once the cap is removed can be placed on the sterile drap. The cover screw is safely retained by the cap.

Step 3

Once the cap is removed engage the implant using the specific implant carrier, manually or using the handpiece.

Twist drill 3.1 (Bone D1)

In the presence of very compact bone, develops a wider site, facilitating the insertion of the implant.

Speed 800-1200 RPM, 25-30 Ncm torque and with abundant irrigation.

Cortical Drill 3.5 (Bone D1, D2)

Allows the placing of the implant neck in presence of compact bone.


Pilot drill 2.0 (Optional)

The portion between the atraumatic tip and the first notch allows to drive the transition to the following twist drill.


Twist drill 2.8 mm

Allows to reach the desired depth (based on the marks on the drill) with a suitable diameter for insertion of the selected implant. It will be used with a back and forth movement, keeping pression in the bone for 1-2 sec.

Speed 800-1200 RPM Torque 25-30 Ncm and with abundant irrigation.

Cover Screw

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Finalizing surgical procedure

One stage procedure

Using a light hand force (5-10 Ncm), insert the healing abutment with selected length and diameter. Adapting and suture accurately the tissues around the healing abutment.A one stage surgical procedure may include a temporary prosthetic restoration placed on a temporary abutment.

Two stage procedure

Cover screw installingTake the screw cover from the implant package and insert and screw it manually with a light torque. Carefully replace the flaps above the cover screw and suture.

Healing abutment installing After an adequate period of healing, expose the cover screw and remove it using the screwdriver. Then install the selected healing abutment.

Placing the implant

WARNING

Assess precisely the depth of drilling before implant placement using a depth gauge.Install the implant into the osteotomy without irrigation, using low speed (20 rpm) and a torque value between 25 and 45 Ncm.The final tightening and / or verification of implant stability can be done manually using the Manual Torque wrench.Very high torque values may result in an unwanted bone compression.In addition, a higher torque (over 60-70N) could cause deformations of implant connection components. Therefore, under these conditions remove the implant, use a larger diameter twist drill and reinsert the implant.

Implant Placement

To reach the advantage of internal conical connection and minimize the peri-implant bone resorption, it is recommended to place the implant head 1mm below the bone crest. Placement of the implant in sub-crestal position, promotes the formation of new bone above the edge of the implant platform. This provides further support for the overlying soft tissue and a better prospect for long-term aesthetics of the hard and soft tissues The implant can, however, be located, without any problems, even in the crestal position. This way reduces the benefit from the prosthetic abutment subcrestal positioning, but there is no negative consequence from the biological point of view.

Disconnect the implant

Once you have completely inserted the implant, simply remove the implant driver from the head of the implant. Then install on the implant a cover screw or a healing abutment.

Implant surgery

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Implant surgery

The CLC CONIC IMPLANT can be inserted in an angled position, the axis of the corresponding crown. However, as the tests, according to ISO 14801-2008, should be avoided an angle between implants greater than 30 degrees, that expose the implant and the abutment to excessive mechanical stress, may predispose them to fracture.

MAX 30°

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Prosthetic procedures

CEMENT RETAINED PROSTHESIS

DIRECT TO IMPLANT SCREWED PROSTHESIS

CONNECTOR SCREWED PROSTHESIS

ATTACH RETAINED OVERDENTURE

BAR RETAINED OVERDENTURE

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Implant pick up

Definitive Prosthetic Abutment

Standard and angulated Abutment

Single crown Partial Bridge Full arch bridge

Implant replica Temporary Prosthetic Abutment

Cement retained prosthesis

Cad Cam Cemented abutment

Titanium base for Zirconium Abutment

Titanium base

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Operations sequence

Healing abutments on implants placed

Open impression tray placement

Healing abutments removal by Hex driver handle

Unscrewing of pick up retention screws by Hex driver handle

Implants Removal of pick up retention screws

Pick up insertion, screwed with a light force by Hex driver handle

Removal of impression tray with pick up

Impression material appliance on the pick up

impression tray with pick up is sent to the laboratory for casting the model

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Insertion of implant replica screwed to the corresponding pick up

Crowns bridge wax on implant replica

Pink Soft resin for gum replica Silicon impression ofCrowns bridge wax

Plaster master cast mounting Screwing of lab red retention screws after abutment placement

Master cast with pick up Abutment of prosthesis screwed on the connector replica

Master cast with implant replica after pick up removal

Analysis of prosthesis abutments reduction

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Trimming of coronal portion of prosthesis abutments based on crowns bridge dimension

Wax bridge reduction to realize the metal framework of the ceramic bridge

Evaluation of Prosthesis abutments dimension and direction

Evaluation of the wax framework dimension

Trimming of Prosthesis abutments by tungsten carbide burr

Displacement of the wax framework of the ceramic bridge

Final Evaluation of Prosthesis abutments dimension and direction

Wax framework of the ceramic bridge ready for the merger

Wax bridge framework placement on the reduced prosthesis abutments

Wax framework placement into the melting oven

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Metal framework

Ceramic bridge test on the master cast

Metal framework test on the prosthesis abutments placed in the master cast

Resin positioning jig prostehsis abutment placement

Metal framework test on the master cast

Positioning JIG removal with prosthesis abutments

Prosthesis abutments on the corresponding implants

Metal framework test on the prosthesis abutments placed in the patient mouth

Positioning JIG placement in patient mouth with prosthesis abutments

Ceramic structure on the metal framework

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Ceramic bridge after careful removal of cement excesses

Final Prosthesis abutment screwing by ratchet wrench at 25N

Closure of prosthesis abutment access holes

Ceramic bridge placement by cement retention

Prosthesis abutment retention screws screwing by Hex driver handle

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Direct to implant screwed prosthesis

Implant pick up


Implant replica

Anti rotational temporary standard abutment

Temporary Prosthetic Abutment

Titanium base + Bourn out abutment

Single crown


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Operations sequence

Healing abutmens on implant placed


Healing abutment removal by Hex driver handle

Unscrewing of pick up retention screw by Hex driver handle

Implant Removal of impression tray with pick up

Pick up insertion, screwed with a light force by Hex driver handle


Impression material appliance on the pick up

Insertion of implant replica screwed to the corresponding pick up

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Pink Soft resin for gum replica Crown wax on implant replica

Plaster master cast mounting Silicon impression of Crown wax

Master cast with pick up Screwing of Titanium base

Master cast with pick up removal

Bourn out abutment placement

Master cast with implant replica after pick up removal

Bourn out abutment on titanium base

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Analysis of bourn out abutment reduction by Silicon impression of Crown wax

Evaluation of the dimension of the wax framework of the ceramic crown

Bourn out abutment reduced Displacement of the wax framework and bourn out abutment

Evaluation of abutments dimension and direction

Wax framework and bourn out abutment ready for the merger

Wax crown placement on the reduced abutment

Wax framework and bourn out abutment placement into the melting oven

The wax crown on the reduced bourn out abutment

Metal framework

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Metal framework test on the Titanium base

Red laboratory screw removalMetal framework test on the master cast

Ceramic crown removalCeramic structure on the metal framework

Ceramic crown positioning on the master cast

Bonding of ceramic crown on Titanium base

Ceramic crown bonded to the Titanium base

Ceramic crown positioned on the master cast

Unscrewing of ceramic crown and Titanium base

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Ceramic crown after access holes closure

Ceramic crown positioning in the patient mouth

Ceramic crown positioned in the patient mouth

Ceramic crown retention screw screwed by Hex driver handle

Ceramic crown retention screw screwed by ratchet wrench at 25 N

Unscrewing of ceramic crown

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+

Connettor standard 40°

Partial Bridge Full arch bridge Toronto

Pick up St-Con

Connector screwed prosthesis

Replica St-Con Temporary Abutment St Con


Titanium Base + Bourn Out Abutment St Con

Bourn Out Abutment St Con

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Operations sequence

Healing abutments on implants placed

Removal of impression tray with connector pick up

Healing abutments removal by Hex driver handle

Implants

Insertion of suitable connector abutments by Hex driver handle. The height of the selected connector is based on the perimplant mucosa dimension

Connector abutments screwed to the implant morse taper connection

Connector abutments pick up screwed by Hex driver handle with a light force

Impression material appliance on the connector pick up


Unscrewing of connector pick up retention screws

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Master cast with connector replica after connector pick up removal

Insertion of implant replica screwed to the corresponding connector pick up

Crowns bridge wax on connector replica

Pink Soft resin for gum replica Silicon impression of Crowns bridge wax

Plaster master cast mounting Titanium base+ bourn out abutments placement

Master cast with connector pick up

Screwing of laboratory red retention screws

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Analysis of connector abutments reduction

Displacement of the wax framework with the bourn out abutment

Trimming of bourn out abutments based on crowns bridge dimension

Wax framework of the ceramic bridge and bourn out abutment ready for the merger

Evaluation of connector abutments dimension and direction

Wax framework and bourn out abutment placement into the melting oven

Wax bridge framework placement on the reduced prosthesis abutments

Metal framework

Evaluation of the dimension of the wax framework

Metal framework test on the Titanium base

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Metal framework test on the master cast

ceramic bridge bonded to the Titanium base

Ceramic structure on the metal framework

Unscrewing of ceramic bridge and Titanium base

Titanium base

Red laboratory screws removalBonding agent on the Titanium base

Bonding of ceramic bridge on Titanium base

ceramic bridge with the access holes

Bonding agent to be removed

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Final Ceramic bridge retention screws screwed by ratchet wrench at 15-20 N

Ceramic bridge retention screws screwed by ratchet wrench at 15-20 N

Ceramic bridge after access holes closure

Ceramic bridge retention screws screwed by Hex driver handle

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Attach retained overdenture

Sfero inox ball housing

Sfero plastic pink insert

Sfero block

Placement of implants for a sfero block retained overdenture should be planned based on an existing good denture or on a complete wax up for a new denture.

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Operations sequence

Connect the Sfero Inox Ball Housing to the Sfero Plastic Insert.

Connect the Sfero Inox Ball Housing and the Sfero Plastic Insert to the Sfero Block attachment.

In the lower jaw, a minimum of 2 implants can be sufficient.

But for a best retention and stability, four implants should be placed.

In the upper jaw, instead, a minimum of 4 implants are requested

Following a complete healing period, an assessment of the distance between the top of the implant and the highest level of peri-implant mucosa must be calculated.

Depending on that distance, the suitable sfero-block abutment is chosen.Sfero Block abutment should never be positioned under the mucosal tissue.

Use a sfero block driver to install each abutment. Using a clockwise movement, engage the abutment within the internal cone morse portion of the implant and use a torque wrench of 20N to secure the seating.

Place a plastic disc over the active segment of the attachment.

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Create a cavity within the denture base above the implant sites, leaving a space of 2 mm around the attachment housing.

Try –in the denture, asking the patient to bite down, to ensure it seats without any distorsion.

Mix a self curing acrylic resin. Cover housing and fill prepared cavities within the denture base.

Fit the denture and ask the patient to bite down all the way.Wait until resin is completely cured.

Inspect for voids and if needed, add small amounts of pink acrylic resin to ensure that housing are completely embedded in resin and always placed denture in the mouth, completely seated under occlusal pressure.Adjust and remove excess resin if present around the housing.

Caps will require periodic replacement, typically once very year.Replacement times are depending on multiple factors including: number of implants/attachments, relative inclination of implants, hygiene habits of patients etc…

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Bar retained overdenture

Connettor standard 40°

Pick up St-Con

Replica St-Con

Titanium Base + Bourn Out Abutment St Con

Bourn Out Abutment St Con

Implant Bar Overdentures offer a removable implant solution for edentulous patients desiring a stable and esthetic prosthesis that improves retention, function and speech.

Before moving forward with the Implant Bar Overdenture option, consider anterior-posterior spread and keep in mind that 12 mm or more of vertical clearance is required. Although a closed-tray impression technique is described here, open-tray impressions are acceptable.

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Operations sequence

Master cast with connector replicas.

Titanium base+ bourn out abutment placement.

Screwing of red laboratory retention screws Titanium base + bourn out abutments.

Remove the healing abutments from the implants.

Insert the connector of the suitable height and tighten the screw.

Seat the coping pick up and tighten the screws.

Take a connector-level impression of the edentulous arch.

Allow the material to completely set before loosening the screws and removing the impression tray

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Final titanium bar.

The bar contoured to connect implant together, runs parallel residual ridge.

Wax bar on connectors.

Titanium bar and retention clips.

Wax framework to be seated in the prosthesis overlying the bar .

Final metal framework seated in the prosthesis showing retention clips and their relative places in the metal framework seated in the final prosthesis.

Titanium bar seated on oral implant connectors in the patient mouth.

Final metal framework to be seated in the prosthesis overlying the bar .

Tighten of Titanium bar retention screws.

Closure of titanium bar holes. The final prosthesis with retention clips is seated on the titanium bar.

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Disinfection and Sterilization

How you clean and sterilize your CLC instruments is important, and this guide will address four basic aspects:

REUSABILITY

THE STERILIZATION PROCESS

MATERIALS AND DISINFECTANT PRODUCTS

CLEANING TECHNIQUE

A team of highly specialized technicians are in charge of guaranteeing the high standards of quality demanded by CLC Conic. However, it is not enough that CLC produces reliable and high precision instruments, these need to be looked after properly and each device used only for its intended purpose. All instruments must be cleaned, disinfected and sterilized before

every use so as to avoid the risk of contamination from patient to patient.Responsibility for the cleaning of CLC instruments and for the regular maintainance of equipment used for this purpose lies with you. This guide aims to provide you with all the necessary information on how best to maintain CLC instruments.

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ReusabilityCareful handling and cleaning techniques are essential to maintain the correct functionality of CLC instruments. It is important to keep a record of the number of uses of cutting instruments since they can only be reused up to a maximum of 20 times (e.g. 1 time = placement of 1 implant).CLC provides an appropriate tracking sheet to help ensure that the number of uses of cutting instruments is recorded.

Article Code Dim. Number of surgical procedures

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Direction Drill LCDR01 ø 2,0 mm

Marker Drill CODR04 ø 4,0 mm

Twist Drill TDCL216 ø 2,0 mm

TDCL2816 ø 2,8 mm

TDCL3316 ø 3,3 mm

TDCL3816 ø 3,8 mm

TDCL4216D ø 4,2 mm

TDCL5216 ø 5,2 mm

Pilot Drill PDCL28 ø 2,0-2,8 mm

PDCL33 ø 2,8-3,3 mm

PDCL38 ø 3,3-3,8 mm

PDCL42 ø 3,8-4,2 mm

PDCL52 ø 4,2-5,2 mm

Conturesink CSCL35 ø 3,5 mm

CSCL4 ø 4,0 mm

CSCL45 ø 4,5 mm

CSCL5 ø 5,0 mm

CSCL6D ø 6,0 mm

Twist Drill D1 Bone

TDCL3616 ø 3,6 mm

TDCL416 ø 4,0 mm

TDCL4516 ø 4,5 mm

TDCL5516 ø 5,5 mm

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The Sterilization Process

Sterilization is a process that kills microorganisms and their spores. Prior decontamination and cleaning of instruments is essential because the reduction of the quality/quantity of the microbial load (bio-burden) is the key to successful sterilization. • After surgery, CLC recommend you process contaminated instruments as quickly as

possible for cleaning.• Use appropriate protective clothing and gloves for this operation. • Make sure that instruments are undamaged. Damaged instruments should be collected

and disposed of separately.• Contaminated instruments must be placed carefully and separately into rigid containers

and transferred to the area where decontamination is performed to reduce the microbial load prior to cleaning.

• Decontamination is performed in order to reduce the microbial load before manual or mechanical cleaning, it is a pre-treatment and cannot replace cleaning or the sterilization process.

• Multiple-piece instruments such as the ratchet wrench must be disassembled into their separate parts.

1. Collect

5. Drying

3. Cleaning

7. Packaging

2. Decontamination

2. Decontamination

6. Inspection

4. Rising

8. Steam sterilization

9. Storage

25-55 nCRIC02

0-35 nCRIC01

1. Collect

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After the manual decontamination phase, the instruments must be subjected to a rigorous cleaning procedure, which is intended to remove residues of organic and inorganic substances and, consequently, also micro-organisms.Manual cleaning is impractical and is therefore not recommended for implant instruments. Owing to its lower effectiveness and reliability, this method should be used only if a mechanical method is unavailable. • We only recommend manual cleaning prior to sterilization for CLC

instrument trays.• The material to be cleaned must be immersed in a solution of

detergent liquid, which can be based on surfactants, enzyme, multi-enzyme, with PH between 5 and 9.

• Always adhere to the manufacturer’s recommendations for temperatures, concentrations and exposure durations.

Ultrasound cleaning: CLC recommend cleaning implant instruments (surgical drills, surgical and prosthetic tools, torque wrenches/ratchets) with the ultrasound system which, when performed correctly, ensures thorough cleaning and respect of materials.

Ultrasound cleaningA good result is attained if the following points are rigidly adhered to: • Instruments must be of the same material.• Follow the manufacturer’s recommendations and solution concentration

(appropriate cleaning agent for material, neutral, non-corrosive), water temperature around 40 ° C (based on the solution used), the ultrasound frequency around 35 KHz, exposure time (minimum 5 minutes).

• Instruments must be completely immersed in the solution, jointed or hinged items should be in an open position, items must be placed in such a way that there is no overlapping.

• To improve the effectiveness of the ultrasonic bath, cleaning without the lid is recommended.

• The cleaning solution must be replaced at regular intervals in accordance with the manufacturer’s instructions. This will depend on the frequency and conditions of use but, in any event, at least once daily.

mm 200x154x73KIT01

• After manual or mechanical cleaning with ultrasound, CLC recommend rinsing instruments

in demineralized water as this does not leave stains.

Instruments must be dried thoroughly in order to avoid any risk of corrosion. The following can be used:• Filtered compressed air• Towels

• Check all instruments to make sure they are clean and intact; pay special attention to critical

areas such as handle structures, joints and blind holes.• Examine carefully for signs of corrosion.• If the instruments are still contaminated, they must be cleaned and disinfected anew.• Reassemble any instruments which have been taken apart such as the ratchet wrench.

Use sterile bags suitable for saturated steam. Pack the materials:• Singly: a standard packaging material may be used. Ensure that the pouch is large enough

to contain the instrument without stressing the seal.• In their case: the CLC case is designed for steam sterilization up to 134°. Place the instruments

into the CLC case and place the loaded case into an appropriate sterilization pouch.

• Sort the instruments into groups according to material so they can be processed separately

• Soak the instruments in a cleansing and disinfecting aldehyde-free solution with a pH between 5 and 9. The solution must be compatible with the material of the instruments.

• Exposure time will depend on the characteristics of the solution employed and the producer’s recommendations should be followed.

• Thoroughly rinse out all cavities in the instruments using a disposable syringe

• Use only a soft brush for the manual removal of residual matter. • Shift movable parts forwards and backwards

After decontamination, instruments are removed and go on to the next stage of washing. The solution must be disposed of in compliance with current regulations.

3. Cleaning

5. Drying

7. Packaging

6. Inspection

4. Rising

94 95

• Steam sterilization involves the use of steam under pressure, delivered

at a particular temperature for an appropriate time. Devices used for the purpose of steam sterilization are called autoclaves, or steam sterilizers. The relationships between the three physical parameters (time, temperature and pressure) are given by the European Pharmacopoeia and European regulations on steam sterilization (EN 285, EN 554).

• Instruments and sterilization cases must not be exposed to temperatures higher than 134 °C (273 °F).

• It is important to regularly inspect and clean the sterilization unit and instruments: rust particles from corroded instruments may contaminate instruments in all future sterilization cycles.

• We recommend labelling pouches before sterilizing. This will facilitate recall of items in the event that monitoring detects a problem with a sterilizer.

• When sterilizing multiple instruments in one autoclave cycle, ensure the the sterilizer’s maximum load is not exceeded. Refer to the sterilizer’s instructions for use

• The part of the sterile pouch made of paper has to be placed face up and must not protrude over the edge of the tray.

• When removing the sterilized pouch from the sterilizer, check that the internal/external indicator tapes have turned the appropriate colour according to the manufacturer’s instructions.

Principal causes of failure of steam sterilization:

• Incorrect wrapping of instruments (packaging the instruments when they are wet)

• Incorrect loading of the steam sterilizer • Air bubbles in the sterile pouches• Wet packs

• Never store the sterile pouches when they are still wet or moist. • Instruments must be conserved inside their pouch at room temperature (18°-25°). • Use sterilized instruments within the period indicated by the producer of the sterile pouches.

Symbol Description Symbol Description

Consult instructions for use

Do not reuse

Batch code Producer

Catalogue numberKeep away from sunlight

Use by Store in a dry place

Do not resterilise caution

Sterilized with ionizing radiation

Do not use if the packaging is not intact

8. Steam sterilization 9. Storage

96 97

Materials and incompatible ingredients

• Different materials require different disinfectants and cleaning agents. Placing all instruments together, without taking this into account, will result in an increased risk of contact corrosion.

• The instruments must be separated into groups according to their material composition. For this reason, CLC recommend you do not disinfect, clean or sterilize instruments made of different materials together.

CLC instruments are made of:

• Stainless steel • Titanium• Plastic

In the following table, we identify disinfectants and cleaning agents incompatible with the different materials and the negative consequences of their use.

In the following table, we identify some common cleaning error, their negative consequences and their prevetion.

Material Incompatible Ingredients Consequence

Stainless steelChlorine, oxalic acid, hydrogen peroxide (H2O2).

Pitting and contact corrosion.

Titanium

Chlorine, oxidizing acids (nitric acid, sulfuric acid, oxalic acid), hydrogen peroxide (H2O2).

Discoloration.

AluminiumPH value outside the range of 5–8.

Destruction of the oxide layer which leads to an increase in susceptibility to corrosion.

Plastic

Organic solvents (alcohols, ethers, ketones and benzines), hydrogen peroxide (H2O2), aldehyde, halogens (chlorine, iodine, bromine).

Deformation and destruction.

Error Consequence Prevention

Allowing surgical residues (blood, body fluids, tissue residues) to dry on an instrument.

Corrosion, rusting. Clean the instruments immediately after surgery.

Using incorrect cleaning agents and disinfectants.

Corrosion, pitting, discoloration, deformation.

Only use cleaning agents and disinfectants intended for the material and follow the manufacturer’s instructions for use.

Using steel wool and steel brushes.

Corrosion and destruction of the material surface.

Use soft brushes only.

Mixing instruments of dissimilar materials.

Corrosion.Do not mix instruments of dissimilar materials.

Impurities in the sterilizer.Initial rust and later contamination of instruments with rust.

Maintain the sterilizer correctly.

Insufficient rinsing and drying. Corrosion, rust.Rinse and dry the instruments very thoroughly.

Exposing instruments to temperatures higher than 134 °C (273 °F).

Destruction, discoloration, deformation.

Do not expose instruments to temperatures higher than 134 °C (273 °F).

Cleaning technique

Cleaning adviceWhile placing all the instruments together will result in an increased risk of contact corrosion, it is also true that exposing instruments to moisture for long periods of time may lead to damage.

• CLC recommend you use only cleaning agents and disinfectants intended for the material in question and follow the manufacturers’ instructions for use.

• CLC avoid using products which contain the following ingredients: organic, mineral and oxidizing acids or strong alkalis (pH value outside the 5-9 range), organic solvents (alcohols, benzines ethers, ketones), oxidation agents, halogens (bromine, chlorine, iodine), aldehydes, aromatic/halogenized hydrocarbons and heavy metal salts.

www.clcscientific.com

Via Vecchia Ferriera, 1836100 Vicenza - ItalyTel. +39 0444 291168

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