Sure / Dental Innovations |
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PANAVIA
21
Technique Sheet |
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Instructions for Use
KURARAY CO., LTD.
PANAVIA 21 – Kit Components
- PANAVIA
21 paste
Catalyst paste 4ml
Universal paste (EX, TC or OP) 4ml
- ED
PRIMER
Liquid A 4ml
Liquid B 4ml
- OXYGUARD
II 6 ml
- PANAVIA
ETCHING AGENT V 5ml
- Mixing
Pads (50 sheets)
- Spatula
- Mixing
Dish
- Small
Sponge Pledgets
- Disposable
Brush Tips (50X2)
- Brush
Tip Handles (2)
I. CLINICAL FEATURES
PANAVIA 21 is an advanced adhesive resin cement with
improved dispensing, handling and bond strength properties.
- PANAVIA
21 is available as a Catalyst paste and Universal paste incorporated into
a dispensing unit that ensures convenient and accurate mixes during each
use.
- PANAVIA
21 can be quickly mixed into a uniform paste and easily applied in all
clinically indicated situations.
The anaerobic setting properties of PANAIVA 21 provide extended
working time and trouble free clean-up.
- PANAVIA
21, in conjunction with ED PRIMER, gives high bond strengths between
metal, silanated porcelain or cured composite and enamel or dentin.
PANAVIA 21 paste consists of Universal and Catalyst pastes,
each being a low viscosity composite resin.
It contains the adhesive monomer MDP (10-Methacryloyloxydecyl dihydrogen
phosphate) which provides long-term bond strength between tooth structure and
metal, silanated porcelain or composite.
The newly developed adhesion primer, ED PRIMER, contains
HEMA and 5-NMSA as well as MDP and consists of Liquid A and Liquid B. ED PRIMER, when applied to enamel and
dentin, promotes a strong bond between PANAVIA 21 paste and tooth
structure. Acid etching of dentin and
cut enamel is not required with ED PRIMER; only uncut enamel is etched.
OXYGUARD II is a viscous gel used to block the oxygen from
anaerobic setting PANAVIA 21 paste.
Applied to the restoration’s margin, it also contains a polymerization
accelerator to provide more effective setting.
The highly viscous PANAVIA ETCHING AGENT V is an
approximately 40% phosphoric acid gel (50% aqueous phosphoric acid + thickener)
that is used to etch uncut enamel and to activate roughened porcelain prior to
ED PRIMER or PANAVIA 21 application.
II. PHYSICAL PROPERTIES
A. Shear bond strength;
Enamel
Etched
Enamel
Dentin
Ni-Cr alloy
*1
Gold alloy
*2
Porcelain
*3
Cured
composite *3
Fresh
amalgam
24hr:
Stored in water at 37deg C for 24 hours
TC 3000:
Thermal cycled between 4deg C and 60deg C for one minute each
*1
Sandblasted
*2
Sandblasted and tin-plated
*3
Silanated with CLEARFIL PORCELAIN BOND
B. Compressive strength; 290 Mpa
C. Flexural strength; 77 Mpa
D. Film thickness; 19 microns
E. Solubility; 1.4ug/mm3
F. Water absorption; 20ug/mm3
G. Working and setting time;
Mixing (at
25deg C) 20-30
sec
Working
time (at 25deg C) 4 min
Setting
time from time of
seating (at
35deg C) 1 min
Complete
setting (at 35deg C) 3 min
III. INDICATIONS
PANAVIA 21 is available in three radiopaque shades: EX is
partially translucent and white in color, TC is very translucent and tooth
colored and OP is very opaque and dentin colored.
PANAVIA 21 is indicated in the following clinical
situations:
- Cementation
of adhesion bridges or splints
- Cementation
of metal crowns, bridges and inlays/onlays
- Cementation
of silanated porcelain and cured composite crowns or inlays/onlays
- Cementation
of preformed posts or cast post and cores
- Bonded
amalgam restorations
EX, TC, OP INDICATION MATRIX
EX TC OP
(standard
(tooth (opaque)
white) color)
Anterior adhesion bridge and splint ADQ NOT
REC REC
Posterior adhesion bridge and splint REC REC REC
Metal inlay, onlay, crown and bridge REC REC ADQ
Silanated porcelain or cured
composite inlay, onlay and crown NOT REC REC NOT REC
Preformed post/Cast post and core REC REC REC
Amalgam bonding REC ADQ REC
REC; RECOMMENDED
ADQ; ADEQUATE NOT REC; NOT
RECOMMENDED
IV. CLINICAL PROCEDURES
A. Cementation of Adhesion Bridges or Splints
Treatment
of Tooth Structure
- Prepare
the abutment teeth allowing for proper retention grooves and occlusal rests.
(Fig. A1)
- All
uncut enamel areas should be etched twice with PANAVIA ETCHING AGENT V.
(Fig. A-2) Buccal surfaces should be etched for 30 seconds, washed and
dried, then re-etched for 30 seconds.
Lingual surfaces should be etched for 30 seconds, washed and dried,
then re-etched for 60 seconds.
NOTE: It is not necessary to acid-etch cut enamel or dentin surfaces
when cementing with
PANAVIA 21.
- Dispense
one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing
dish and mix for three-five seconds. (Fig. A-3) Using a small sponge
pledget apply the mixture to the prepared tooth surface. (Fig. A-4) After
60 seconds evaporate the volatiles with a gentle stream of air; the
surface will appear glossy.
NOTE: Do not apply ED PRIMER to the metal or silanated porcelain. Do not rinse.
Treatment
of Metal
- Non-precious
metals should be sandblasted with 30-50 micron alumina particles at an air
pressure of 4.2-7 kg/cm2 (60-100 PSI); two to three seconds per cm2 will
remove the luster producing a matte finish. (Fig. A-5)
- Precious
and semi-precious metals should be sandblasted as above and them
tin-plated. (Fig. A-6) A layer of tin approximately 0.5 microns thick
should be deposited. To avoid
contamination do not touch the tin-plated surfaces.
- After
sandblasting and after tin-plating, wash the casting in a stream of water
for one minute then ultrasonically clean for two-three minutes in a
neutral detergent solution. (Fig. A-7)
NOTE: The prepared tooth surface and casting must be kept dry and
contamination free.
Usage of PANAVIA 21 paste
- Remove
the syringe cap and slowly rotate the dispensing knob ONE FULL TURN
clockwise until it clicks. (Fig. A-8) This dispenses the proper ratio and
amount of PANAVIA 21 Catalyst and Universal for the cementation of an
adhesion bridge with two abutments.
If more PANAVIA 21 paste is required, dispense an additional FULL
TURN.
NOTE: PANAVIA 21 paste must always be dispensed in increments of full
turns.
- Mix
the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a
smooth, uniform paste. (Fig. A-9) Because of PANAVIA 21’s anaerobic
properties the mix should be spread in a thin layer on the pad until ready
to use.
Setting the Adhesion Bridge or Splint
- Apply
a thin, even layer of PANAVIA 21 paste to the prepared, cleaned and dried
metal surface, being careful to avoid air entrapment. (Fig. A-10)
NOTE: DO NOT additionally apply PANAVIA 21 paste to the tooth surface
primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.
- Seat
the restoration and apply finger pressure. (Fig. A-11) After about 60
seconds release pressure and remove the excess PANAVIA 21 at the margins
with a small disposable brush tip starting first with the proximal
surfaces. (Fig. A-12)
- With a
disposable brush tip apply OXYGUARD II to the margin. (Fig. A-13) After
three minutes remove the OXYGUARD II with a cotton roll and water spray.
- Any
slight excess of PANAVIA 21 remaining at the margin can be removed with an
explorer or small scaler. The
restoration can then be finished and polished with pumice and water. (Fig.
A-14)
B. Cementation of Metal Crowns, Bridges or Inlays/Onlays
Treatment of Tooth Structure
- The
crown or cavity preparation should be in the normal manner. (Fig. B-1)
Direct pulp exposures should be covered with calcium hydroxide.
- Dispense
one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing
dish and mix for three-five seconds.
Using a small sponge pledget apply the mixture to both the dentin
and enamel simultaneously. (Fig. B-2) After 60 seconds evaporate the
volatiles with a gentle stream of air; the surface will appear glossy.
NOTE: Do not apply ED PRIMER to the metal. Do not rinse.
Treatment of Metal
- Non-precious
metals should be sandblasted with 30-50 micron alumina particles at an air
pressure of 4.2-7 kg/cm2 (60-100 PSI); two to three seconds per cm2 will
remove the luster producing a matte finish. (Fig. B-3)
- Precious
and semi-precious metals should be sandblasted as above and then
tin-plated. (Fig. B-4) A layer of tin approximately 0.5 microns thick
should be deposited. To avoid
contamination do not touch the tin-plated surface.
- After
sandblasting and after tin-plating, wash the casting in a stream of water
for one minute then ultrasonically clean for two-three minutes in a
neutral detergent solution.
NOTE: The prepared tooth surface and casting must be kept dry and
contamination free.
Usage of PANAVIA paste
- Remove
the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise
until it clicks. This dispenses
the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the
cementation of one full crown. If
more PANAVIA 21 paste is required, dispense an additional FULL TURN.
NOTE: PANAVIA 21 paste must always be dispensed in increments of full
turns.
- Mix
the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a
smooth, uniform paste. Because of
PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer
on the pad until ready to use.
Seating the Crown, Bridge or Inlay/Onlay
- Apply
a thin, even layer of PANAVIA 21 paste to the prepared, cleaned and dried
metal surface, being careful to avoid air entrapment. (Fig B-5)
NOTE: DO NOT additionally apply PANAVIA 21 paste to the tooth surface
primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.
- Seat
the restoration and apply finger pressure. (Fig. B-6) After about 60
seconds release pressure and remove the excess PANAVIA 21 at the margins
with a disposable brush tip starting first with the proximal surfaces.
(Fig. B-7)
- With
a disposable brush tip apply OXYGUARD II to the margin. (Fig. B-8) After
three minutes remove the OXYGUARD II with a cotton roll and water spray.
- Any
slight excess of PANAVIA 21 remaining at the margin can be removed with an
explorer or small scaler. The
restoration can then be finished and polished with pumice and water. (Fig.
B-9)
C. Cementation of Silanated Porcelain and Cured Composite
Crowns or Inlays/Onlays
Marginal adaptation is an important factor on occlusal surfaces.
Since cement wear is higher than restoration wear, it is recommended that a
marginal gap of over 50 microns not be accepted for occlusal surface
restorations.
Treatment
of Tooth Structure
- The
crown or cavity preparation should be in the normal manner. (Fig. C-1)
Direct pulp exposures should be covered with calcium hydroxide.
- Dispense
one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing
dish and mix for three-five seconds.
Using a small sponge pledget apply the mixture to both the dentin
and enamel simultaneously. (Fig. C-2) After 60 seconds evaporate the
volatiles with a gentle stream of air; the surface will appear glossy.
NOTE: Do not apply ED PRIMER to the
silanated porcelain or cured composite.
Do not rinse.
Treatment of Porcelain
- To
maximize surface area, sandblast the internal surface with 30-50 micron
alumina particles at an air pressure of 4.2-7 kg/cm2 (60-100 PSI) for
two-three seconds per cm2. (Fig. C-3) Clean ultrasonically in water for
two minutes.
- Activate
the roughened porcelain surface by applying PANAVIA ETCHING AGENT V for
five seconds; wash and dry. (Fig. C-4)
- Silanate
the internal surface of the restoration with CLEARFIL PORCELAIN BOND
ACTIVATOR mixed with either CLEARFIL NEW BOND or CLEARFIL PHOTO BOND per
their Instructions for Use. (Fig. C-5)
Treatment of Cured composite
- Activate
the internal surface of the cured composite by applying PANAVIA ETCHING
AGENT V for five seconds; wash and dry. (Fig. C-6)
- Silanate
the internal surface of the restoration with CLEARFIL PORCELAIN BOND
ACTIVATOR mixed with either CLEARFIL NEW BOND or CLEARFIL PHOTO BOND per
their Instructions for Use.
Usage of PANAVIA 21 paste
- Remove
the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise
until it clicks. This dispenses the proper ratio and amount of PANAVIA 21
Catalyst and Universal for the cementation of one full crown. If more PANAVIA 21 paste is required,
dispense an additional FULL TURN.
NOTE: PANAVIA 21 paste must always
be dispensed in increments of full turns.
- Mix
the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a
smooth, uniform paste. Because of
PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer
on the pad until ready to use.
Seating the Crown or Inlay/Onlay
- Apply
a thin, even layer of PANAVIA 21 paste to the prepared, cleaned and dried
porcelain or composite surface, being careful to avoid air entrapment.
(Fig. C-7)
NOTE: DO NOT additionally apply PANAVIA 21 paste to the tooth surface
primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.
- Seat
the restoration and apply finger pressure. After about 60 seconds release pressure and remove the
excess PANAVIA 21 at the margins with a disposable brush tip starting
first with the proximal surfaces. (Fig. C-8)
- With
a disposable brush tip apply OXYGUARD II to the margin. (Fig. C-9) After
three minutes remove the OXYGUARD II with a cotton roll and water spray.
- Any
slight excess of PANAVIA 21 remaining at the margin can be removed with an
explorer or small scaler. The
restoration can then be finished and polished with pumice and water. (Fig.
C-10)
D. Cementation of Preformed Posts or Cast Post and Cores
Treatment
of Canal
- Remove
filling material and prepare the length and diameter of the canal as
appropriate for the size of post to be placed, or prepare a cast post and
core. (Fig. D-1)
- Dispense
one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing
dish and mix for three-five seconds with a small sponge pledget. Place the mixture on any coronal dentin
and into the canal. (Fig. D-2) After 60 seconds evaporate the volatiles
with a gentle stream of air; the surface will appear glossy.
NOTE: Do not apply ED PRIMER to the metal. Do not rinse.
Treatment of Preformed Post or Cast Post and Core
- Preformed
stainless or titanium posts should be sandblasted with 30-50 micron
alumina particles at an air pressure of 4.2 – 7 kg/cm2 (60-100 PSI); two
to three seconds per cm2 will produce a matte finish. (Fig. D-3)
- Cast
post and core of precious or semi-precious metal should be sandblasted as
above and then tin-plated. (Fig. D-4) A layer of tin approximately 0.5
microns thick should be deposited.
To avoid contamination, do not touch the tin-plated surface.
- After
sandblasting and after tin-plating, wash the post in a stream of water for
one minute then ultrasonically clean for two-three minutes in a neutral
detergent solution.
NOTE: The prepared canal and post must be kept dry and contamination
free.
Usage of PANAVIA 21 paste
- Remove
the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise
until it clicks. This dispenses
the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the
cementation of one preformed post or cast post and core. If more PANAVIA 21 paste is required,
dispense an additional FULL TURN.
NOTE: PANAVIA 21 paste must always
be dispensed in increments of full turns.
- Mix
the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a
smooth, uniform paste. Because of
PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer
on the pad until ready to use.
Seating the Preformed Post or Cast Post and Core
- Apply
a thick, even layer of PANAVIA 21 paste to the prepared, cleaned and dried
post, being careful to avoid air entrapment. (Fig. D-5)
NOTE: DO NOT additionally apply PANAVIA 21 paste to the canal primed
with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.
- Seat
the post and apply pressure for about 60 seconds. (Fig. D-6)
- If a
cast post and core, remove the excess PANAVIA 21 and with a disposable
brush tip apply OXYGUARD II to the margin. (Fig. D-7) After three minutes
remove the OXYGUARD II with a cotton roll and water spray.
- If a
preformed post, and amalgam or composite is being used as a build-up
material, PANAVIA 21 expressed from the canal during post seating can be
used as a cement for the build-up material. (Fig. D-8)
- Continue
with normal abutment and crown procedures.
E. Bonded Amalgam Restorations
Treatment
of Tooth Structure
- Prepare
the cavity in the normal manner for an amalgam restoration. (Fig. E-1)
Direct pulp exposures should be covered with calcium hydroxide. Generally there is no need for cement
liners or bases.
- Dispense
one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing
dish and mix for three-five seconds.
Using a small sponge pledget, apply the mixture to both the dentin
and enamel simultaneously. (Fig. E-2) After 60 seconds evaporate the
volatiles with a gentle stream of air; the surface will appear glossy.
NOTE: Do not rinse.
Usage of PANAVIA 21 paste
- Remove
the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise
until it clicks. This dispenses
the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the
cementation of a large MOD amalgam. If more PANAVIA 21 paste is required,
dispense an additional FULL TURN.
NOTE: PANAVIA 21 paste must always be dispensed in increments of full
turns.
- Mix
the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a
smooth, uniform paste. Because of
PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer
on the pad until ready to use.
Placing the Amalgam
- Apply
a thin, even layer of PANAVIA 21 paste to the entire cavity surface primed
with ED PRIMER being careful to avoid entrapping air. (Fig. E-3)
NOTE: Because ED PRIMER accelerates the set of PANAVIA 21, the PANAVIA
21 paste should be applied to the primed
cavity quickly.
- The
triturated amalgam should be condensed onto the unset PANAVIA 21 paste.
(Fig. E-4)
- Occlusal
carving can be accomplished in the normal manner
- Remove
the matrix and clean the excess PANAVIA 21 paste from the proximal
surfaces with a disposable brush tip.
- Apply
OXYGUARD II to the proximal and occlusal margins. (Fig. E-5) After three
minutes remove the OXYGUARD II with a cotton roll and water spray.
- Any
slight excess of PANAVIA 21 remaining at the margin can be removed with an
explorer or a small scaler. The
restoration can then be finished in the normal manner. (Fig. E-6)
V. REPLACING PANAVIA 21 CATALYST AND UNIVERSAL PASTE
SYRINGES
NOTE: Refill
Catalyst and Universal pastes are supplied as a set containing one syringe of
Catalyst paste and one syringe of Universal EX, Universal TC or Universal OP
paste.
Insertion
guide Syringe Cap Bottom cover plate
Indicator Flange Flange
holder
Dispensing
knob Joint Clutch
- Unsnap
and remove the dispenser’s bottom cover plate.
- The
empty Catalyst and Universal paste syringes are removed together by
gently pulling up on the blue joint of the syringes and lifting them out
of the dispenser.
- Slide
the clutch back toward the dispensing knob until it contacts the stop.
- Insert
the refill Catalyst and Universal paste syringes into the dispenser. The flange on the refill syringe fits
into the flange holder of the dispenser while the blue syringe joint
snaps into the rear of the clutch.
- Replace
the dispenser bottom cover plate and affix the identifying EX, TC or OP
sticker to the top of the dispenser.
- Slowly
dispense one full turn (until you hear the click) of paste to ensure an
accurate amount and ratio for the first clinical use.
Cautions and Recommendations
- PANAVIA
21 paste and ED PRIMER should be stored at refrigerated temperatures when
not in use; bring to room temperature before using.
- Avoid
exposure to direct sunlight or high temperatures.
- PANAVIA
21 paste or ED PRIMER should be immediately removed from skin or clothing
with an alcohol moistened cotton pledget.
- PANAVIA
21 paste or ED PRIMER should be immediately flushed from the eye with
copious amounts of water; consult a physician immediately.
- PANAVIA
ETCHING AGENT should be immediately washed from the face or oral tissue
with water.
- PANAVIA
21 should not be used with any patients known to be hypersensitive to
Methacrylate monomers.
- OXYGUARD
II can be removed from the hands, face or clothing with a water moistened
cotton pledget.
- The
use of protective gloves is recommended during the handling and use
of PANAVIA 21.
- The
syringe cap of the dispenser should be replaced as noted in the insertion
guide.
PANAVIA 21 HAS A SHELF LIFE OF 18 MONTHS FROM THE
DATE OF MANUFACTURE WHEN KEPT REFRIGERATED.
CAUTION: Federal (U.S.A.) law restricts this material to sale by or on the
order of a licensed dentist.
WARRANTY:
Kuraray Co., Ltd. will replace any product that is proved to be
defective. Kuraray Co., Ltd. does not accept liability for any loss or damage,
direct, consequential or special, arising out of the application or use of or the inability to use these products. Before using, the user shall determine the
suitability of the products for the intended use and the user assumes all risk
and liability whatsoever in connection therewith.
NOTE: All data herein is based on research performed
by Kuraray Co., Ltd. and is presented in good faith and without warranty.
CLEARFIL and PANAVIA are registered trademarks of Kuraray
Co., Ltd., Osaka, Japan.
For technical assistance, education and training
information, additional product literature or to order, please call J. Morita
USA, Inc at (800) 752-9729.
.
Manufactured by
KURARAY CO., LTD.
1-12-39, Umeda, Kita-ku Osaka, 530, JAPAN
To Order Please Call 1-888-277-2335