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SURGICAL MANUAL Powered By Docstoc
					                      SURGICAL MANUAL
                          FOR THE

Rev. 6-2007

Table of Contents





The Concept of the Kit

The concept of the “Surgical-Prosthetic Kit” was developed by clinicians to eliminate
confusing inventory and expensive components. All components used in the Bio-Life
System are not interchangeable with other system.

The kit is comprised of a “Surgical Section” which contains the sterile “Implant Body”
(IB) and a sterile “Bone Healing Scre w” (BHC).

The “Prosthetic Section” of the kit as follows…
    Gingival Healing Cap (GHC)
    Threaded Abutme nt (PHS)
    Castable Abutme nt (PHC)
    Laboratory Analog (ANL)

Caution: Federal (USA) law restricts this device to be sold only to a licensed dentist
or physician.

Indications for Use
The Bio-Life dental implant is a two stage implant system intended for use in partially or
fully edentulous mandibles and maxillae, in support of single or multiple- unit
restorations. The Bio-Life dental implant may also function as a terminal or intermediate
support for fixed bridgework.

Contraindications for Use
General Medical Contraindications associated with elective surgical procedures should be
observed. Included, but not limited to, are significant vascular impairment to the implant
site; metabolic bone disease; clotting disorders; current treatment with therapeutic agents
that may have an effect on the surgical site, surrounding tissues or normal healing
responses. For example, drug therapy, chemotherapy, chronic steroid treatment,
anticoagulant therapy, or any other metabolic or physical disorders that interfere with
bone growth, maintenance or wound healing.

   Possible Contraindications:
   1.) Chronic bleeding disorde rs
   2.) Psychological impairment
   3.) Metabolic bone or connective tissue diseases
   4.) Treatment with corticosteroids
   5.) Certain cardiac and vascular diseases
   6.) Diabetes(uncontrolled)
   7.) Treatment with che motherapeutic agents
   8.) Chronic renal disease
   9.) Poor patient oral hygiene
   10.) Para functional habits (Bruxism)

     Temporary Contraindications:
 1.)    Systemic infection; local oral or respiratory infection

     Anatomical or Pathological Contraindications:

     1.) Insufficient alveolar bone width and height (bone volume) to surround the
         entire implant with at least 1mm of bone.
     2.) Inadequate bone height whe re proper implant placement would encroach
         on the mandibular canal.
     3.) Malignancies.

Improper technique can contribute to implant failure and/or loss of bone. The Bio-Life
Dental Implant System is intended to be used only in the indicated applications. Dental
Implants must not be altered in any way. Abutments and attachments supplied by other
implant manufacturers might not be made to the same standards and tolerances as Bio-
Life Dental Implants and should not be substituted. Substitution of components, other
than Bio-Life components, may contribute to implant failure, prosthesis failure, and/or
loss of bone.

The use of electro-surgical instruments or lasers around metallic implants and their
abutments is discouraged due to the potential risk of electric and/or heat conductivity to
the substrate metal.

If the implant becomes contaminated by the patient’s body fluids or tissues in any way,
the implant cannot be used in any other patient. The implant may not be cleaned or re-
sterilized for use in another patient. Do not attempt to decontaminate the implant by any
in-office method.

Modifications to implants (not recommended) and/or abutments may transmit heat to the
implant body and surrounding bone, which may cause bone loss and contribute to implant
failure. External irrigation may prevent bone loss if modifications must be done in the
mouth. All major modifications to abutments must be done outside the mouth with only
minor light modifications made with the abutment in the implant body.

Adverse Reactions
Some of the complications that can occur are: infection, bone loss, patient discomfort,
implant mobility, local soft tissue degeneration, and unfavorable implant placement or

Standard dental treatment procedures should be applied for; infection, bone loss, patient
discomfort, implant mobility, and local soft tissue degeneration as would be indicated
and/or applied to natural teeth. These would include pain medications, antibiotics,
removal from function, removal of mobile implants, and soft tissue/bone de-bridement
and augmentation.

Implant mobility, bone loss, or chronic infection may indicate implant failure. Any
implant that appears to be failing should be treated as soon as possible. If the removal of
the implant is deemed necessary, any soft tissue can be curetted from the implant site and
the site allowed to heal in the same manner as a traumatic natural tooth extraction.

Unfavorable implant placement or alignment may be treated with the use of customized
abutments up to 30 degrees. In the event the implant placement is such that the implant is

unrestorable due to alignment or positioning either with the natural dentition or other
implants, the implant may need to be left unloaded or removed.

The Bio-Life Dental Implant System implants are provided in sterile gamma irradiated
packaging. The inner vial and its contents which contain (the implant body, bone healing
screw and transfer handle) are sterile unless the outer vial seal has been damaged or
opened. Use only sterile, powder free, starch free and talcum free gloves during the

It is important to keep all instrumentation, (surgical hand piece and equipment) sterile to
prevent the possible contamination of the components, the surgical system, and thus the
patient. Always run a system check, and have back- up equipment, implants, and
instrumentation in case of contamination or failure of equipment or instrumentation.

Pre-Operative Procedures
The implant placement procedure should be done under aseptic conditions with
specifically designed sterile surgical instruments. A surgical drilling system with external
irrigation is recommended for drilling the surgical site. The specific drilling sequences
for placement of implants should be followed. When drilling with a pilot, intermediate
and final spade drill use a gentle in and out motion. (Note: Always maintain control of
the drill when entering the bone.) The use of surgical guides, study models and depth
gauges are recommended to aid in implant placement and positioning.

The surgical techniques required to place endosseous dental implants, although described
in some detail in this manual, require highly specialized and complex procedures. Formal
training in the placement of such implants is strongly recommended. Practitioners should
attend courses of study in established techniques of oral implantology.

It is very important to determine local anatomy, and suitability of the available bone
(bone volume) for the implant placement. Adequate radiographs, direct palpation, and
visual inspection of the prospective implant site are necessary prior to treatment, planning
and implant use.

Bio-Life does not provide instruments marked sterile. Non-sterile instruments must be
washed and sterilized prior to use. Always remove instruments from the packaging prior
to sterilization. Double-check your surgical instrumentation to ensure the sterility and

   Cleaning the Surgical Tray

            1. Disassemble surgical kit and wash tray using detergent solution.
               Rinse tray and dry thoroughly.
            2. Place instrume nts in an ultrasound cleanser for 10 minutes.
            3. Remove any visible debris or bone fragments with a soft bristle
            4. Flush inside of inte rnally irrigated instruments with water using a 22
               gauge needle connected to a syringe.
            5. Rinse instrume nts with alcohol to remove soap residue and minerals.
            6. Blot instrume nts dry and allow them to air dry completely.
            7. Return instruments to appropriate location in s urgical tray.
            8. Wrap kit in double layer of autoclave approved paper.
            9. Sterilize kit according to the “Sterilization Table”.

Caution: Drills should be replaced when wear is noted. Bio-Life recommends
replacement of drills after 20 osteotomies.

    Sterilization Table:
             1. Autoclave: 121 degrees C ( 250 degrees F) 15 minutes @ 15psi
             2. Dry Heat: 160 degrees C (320 degrees F) 120 minutes

Surgical Procedures


   1. Pre-plan the initial incision. Conside ration must be given to the contour of
      the attached gingiva and the esthetic require ment of the restoration.

   2. The incision should consider the vascularity of the full thickness flap and the
      preservation of the interproximal papillae.
   3. Sharp dissection is performed firmly to the alveolar bone.

 4. The incision should bisect the attached gingival and bisect the crest of the
    alveolar ridge.

The Full Thickness Flap Production

Preparation of the Osteotomy
The osteotomy site is determined with the surgical guide. The drilling sequence is
comprised of five steps:

  1. The Rosette drill is used to smooth or flatten the crestal bone at the intended
     implant site.

  2. The pilot drill is the next drill used. It is internally irrigated, cuts in 360
     degrees and is used to begin the osteotomy site. The pilot drill is used to
     penetrate the bone to 2/3 the intended depth. The guide pin should be placed
     after the pilot drill has penetr ated the bone to 2/3 depth.

The guide pin demonstrates the emergence profile of the implant and ultimately the
implant abutment.

  3. The third drill in the sequence is the Inter mediate drill. It is end cutting only,
     2.5mm in diameter and is has depth markings of 8, 10, 12, 14, 16mm. This drill
     is used to establish the exact depth needed for the length of the implant

4. Once the exact depth of the osteotomy is achieved, it is recommended to place
   the depth gauge into the site to insure accuracy of depth and to ascertain
   emergence profile again.

5. The last step is the final spade drill. It is the exact diameter of the implant and
   it has depth marking that is 1mm longer than the actual length of the implant
   selected. The depth markings on the final spade drill are: 9, 11, 13, 15, 17mm.

The Completed Osteotomy Site

Implant Placement
The dental implant is in a double vial that is gamma irradiated sterile. Once the
outer vial is removed, the surgeon brings the inner vial to the implant site where
the implant body is removed from the vial and immediately placed into the

The Bio-Life Dental Implant is a Press-Fit type implant and does not require a
bone auger or tapping drill as in the exter nally threaded implant body. The Bio-
Life body is pressed into the osteotomy site with finger pressure.

Final seating of the Bio-Life Dental Implant is completed with off-set seating tool
found in the surgical tray.

Suture and Wound Closure
The final sutures should provide primary closure of the wound area so that the
full thickness flap returns to its original position. The suture should be tight
creating a good seal over the implant bone cover screw.

Post operative instructions are very important to the healing process. Caution
should be taken to avoid trauma to the wound area from an ill-fitting partial or
full denture.

Instruct the patient to follow all post-oper ative instructions, take the prescribed
medications, and report any unusual post-oper ative bleeding or swelling.
Remind your patient about the importance of 2 routine oral exams and cleanings
per year.

Ice or cold packs are recommended for 24 hours following the surgery. Antibiotic
treatment may be initiated post operatively for 7-10 days.

Sutures can be removed in 10 days or as the patient’s soft tissue healing dictates.


A clear Bio-Life surgical guide is placed over the edentulous area to be implanted.
Using the pilot drill, it is placed through the clear surgical guide into the
edentulous gingiva clearly marking the entry point of the implant. The surgical
guide is removed and with the use of the pilot drill, the entry point is deepened
into the crest of the bone ridge, clearly marking the entry point of the implant.

The initial incision is the same as achieved in the placement of the press-fit
implant. Once the gingival flap has been raised, the pilot drill entry point made
prior to the gingival flap should be clearly visible.


 STEP # 1

Using the pilot drill at 6-8,000 rpm, the initial pilot hole is made into the alveolar
ridge to the length of the prescribed implant.

STEP # 2

Use the inter mediate drill 6-8000rpm with capacious water irrigation to precisely
define the final depth of the osteotomy site. (Note the markings on the
intermediate drill are 8, 10, 12,14mm respectively).

STEP # 3

The final drill is the “shaping” drill used to trephine the osteotomy site to the
diameter of the prescribed implant body. The final shaping drill is demarcated in
8, 10, 12,14mm lengths. Using capacious sterile water irrigation, the final shaping
drill is placed into the osteotomy site at 6-8000rpm and it is trephined to the
desired length of the implant body.