Take the stress out of scaling - Dentsply

Apply Oraqix on the
gingival margin around
the selected tooth using the
blunt-tipped applicator.
Wait 30 seconds then fill
Oraqix into the periodontal
pocket until it becomes visible
at the gingival margin. Wait
another 30 seconds before
starting treatment. Longer
waiting time does not
enhance the effect.
The scaling and root planing procedure may begin 30
seconds after application of Oraqix. Anaesthetic effect, as
assessed by probing of pocket depths, has a duration of
approximately 20 minutes.
(Lignocaine 25 mg/g and
Prilocaine 25 mg/g) Periodontal gel
Enhance your patients’ comfort 1
and your business opportunity 2
• Fast – 30-second onset provides 20 minutes of anaesthesia 1 .
• Unique Oraqix Dispenser, easy to load, easy to administer
Take the stress
out of scaling
(Lignocaine 25 mg/g and
Prilocaine 25 mg/g) Periodontal gel
Unique Oraqix Dispenser
• The Oraqix Dispenser is indicated for the administration of Oraqix * .
• Easy loading Oraqix Dispenser provides efficient gel delivery into the periodontal pocket.
• Increased access for hard-to-reach areas.
– Using the double bend technique improves access to periodontal pockets.
– Tip rotates 360° providing flexibility for hard-to-reach areas.
Preparing for Use
• Disinfection & Sterilization
23g Blunt-tipped
Applicator
Double Bend Technique:
Bend cannula twice for
increased accessibility
if needed
– The Oraqix Dispenser can be steam autoclaved after use.
– It is required to allow the Dispenser to cool to room temperature after
autoclaving the device.
– See the Oraqix Dispenser Directions for Use for complete cleaning &
disinfection instructions.
*The Dispenser is contraindicated for use with all injectable, local anaesthetic products.
Unique, easy loading
Oraqix Dispenser.
Ergonomic design for
increased access to all
periodontal pockets.
DENTSPLY (Australia) Pty Ltd ABN 15 004 290 322
11–21 Gilby Road, Mount Waverley, VIC 3149
Tel: 1300 55 29 29 • Fax: 1300 55 31 31
clientservices@dentsply.com
• Patient Friendly – Blunt-tip cannula provides pain-free, direct delivery of
Oraqix gel into periodontal pocket
• Greater patient comfort gives you greater confidence and control
• Enhances your ability to implement full-mouth scaling and root planing
• More comfortable treatment for your patient, improves potential for
recall visits.
Oraqix is not for injection.
Packaging
Individual cartridges of Oraqix are distributed in a blister pack that also
contains a blunt-tipped applicator. Each carton contains 20 cartridges and 20
blunt-tipped applicators.
Order Information
66312020AU Oraqix Gel (box of 20)
66400 Oraqix Dispenser (single pack)
Store Oraqix cartridge below 24°C to avoid gel forming. Refrigerate any gelated
product to return it to the liquid state. Do not freeze. At temperature below 5°C
opaqueness may occur. This opaqueness will disappear when the cartridge is warmed
to room temperature.
To order or for more information on Oraqix, contact your DENTSPLY territory manager.
PBS Information: This product is not listed on the PBS.
Dental Clinicians should review the Product Information for full prescribing information before use.
References: 1. Oraqix Product Information. 2. vanSteenberge D et al: Patient evaluation of a novel non-injectable anesthetic gel: a multicenter
crossover study comparing the gel to infiltration anesthesia during scaling and root planing. J Periodontol 2004; 75(11): 1471 – 1478.
DENTSPLY (N.Z.) Limited
Tel: 0800 33 68 77 • Fax: 0800 33 68 32
clientservicesnz@dentsply.com

Because every
patient deserves
comfortable treatment
Your patients expect more from
their dental practice than ever before.
With Oraqix your patients can enjoy
needle-free pain relief for their scale and
root plane procedure. Patients have no lasting
numbness, improving their overall experience.
Oraqix takes the stress out of scaling
Indications and Usage
Oraqix is indicated for adults who require localized anaesthesia
during scaling and/or root planing.
Product Characteristics 1
A subgingival locally applied anaesthetic gel consisting of a eutectic
mixture of lignocaine and prilocaine in a new thermosetting
system, Oraqix dispenses as a liquid, then sets as a gel in the
periodontal pocket.
• Needle-free blunt-tipped application for quick access
• 30-second onset provides 20 minutes of anaesthesia
• Typically, 1 cartridge or less of Oraqix per quadrant
• Can be re-applied as needed, up to a maximum dose
of 5 cartridges per patient
(Lignocaine 25 mg/g and
Prilocaine 25 mg/g) Periodontal gel
Approved Product Information
ORAQIX ® (Lignocaine 25 mg/g and Prilocaine 25 mg/g) Periodontal Gel
NAME OF THE MEDICINE
Oraqix ® periodontal gel contains lignocaine (25 mg/g) and prilocaine (25 mg/g) as the active
substances.
LIGNOCAINE
PRILOCAINE
CAS number: 137-58-6
CAS number: 721-50-6
Molecular Weight: 234.3
Molecular Weight: 220.3
Description
Oraqix ® periodontal gel is a clear, colourless, oil-in-water microemulsion. Oraqix ® is a low-viscosity
fluid at room temperature and an elastic gel at the temperature in the periodontal pockets.
Excipients: poloxamer (containing butylated hydroxytoluene), hydrochloric acid for pH adjustment to
pH 7.5-8.0 and purified water.
PHARMACOLOGY
Pharmacodynamics
Lignocaine and prilocaine belong to the amide class of local anaesthetic agents which produce a local
blockade of nerve impulses. Local anaesthetics affect the micro-vascular bed, which may cause a
transient paleness or redness.
Oraqix ® is applied directly into the periodontal pockets to provide localised anaesthesia. The onset
of local anaesthesia after application of Oraqix ® in tooth pockets is rapid, about 30 seconds, and a
longer waiting time does not seem to enhance the anaesthesia. The median duration of anaesthesia,
as assessed by probing of pocket depths, is 20 minutes.
Pharmacokinetics
Prilocaine base and lignocaine base are both relatively hydrophilic amino-amides.
Absorption: Lignocaine and prilocaine are absorbed from the oral mucous membranes to a similar
extent. The systemic bioavailability after the highest recommended dose, 8.5 g, is estimated to be
20 to 40% (95% confidence interval) for both drugs. A low bioavailability is expected from the gel
if swallowed, as both lignocaine and prilocaine show a substantial first‐pass hepatic elimination. The
median t max of both drugs is approximately 30 minutes.
Distribution: Lignocaine and prilocaine have an intermediate degree of plasma binding, mainly to
α1-acid glycoprotein, with protein binding of 70% and 40% respectively. The plasma concentration
of lignocaine is higher than that of prilocaine, with mean Cmax values of 0.17 and 0.08 mg/L
respectively after single application of 0.9-3.5 g, and of 0.28 and 0.11 mg/L after a cumulative
dose of 8.5 g Oraqix ® administered as repeated applications during 3 hours.
Biotransformation: Lignocaine is mainly metabolised in the liver and has a high hepatic extraction
ratio (0.65). Prilocaine has a high clearance in excess of normal hepatic blood flow, which suggests
extensive extrahepatic metabolism.
The main metabolism of lignocaine is through N-dealkylation to monoethylglycinexylidide (MEGX)
and glycinexylidide (GX), which is mainly mediated by CYP3A4. These are hydrolysed to 2,6‐xylidine,
which is converted to 4-hydroxy-2,6-xylidine, the major urinary metabolite in man. MEGX has an
antiarrhythmic and convulsant activity similar to that of lignocaine and GX has a weak antiarrhythmic
effect but lacks convulsant activity.
Prilocaine is split at the amide linkage to o-toluidine, which is converted further to 4- and 6-hydroxytoluidine.
The formation of methaemoglobin during treatment with prilocaine is related to the plasma
concentration of o-toluidine and its metabolites. However, even after the maximum recommended
dose of 8.5 g Oraqix ® , individual maximum plasma concentrations of methaemoglobin were within
the normal range (