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Patient Information
Tooth Whitening Gels for Home Treatment
Illuminé™ home tooth whitening gels may be used alone or following treatment with anin-office tooth whitener.
Illuminé home tooth whitening gels contain the active ingredient of carbamide peroxide,which has shown to be most effective for the treatment of tooth discolourations at home.
Illuminé home 10% tooth whitening gel contains 10% carbamide peroxide, releasingH O in a concentration of about 3.6%.
Illuminé home 15% tooth whitening gel contains 15% carbamide peroxide, releasingH O in a concentration of about 5.4%, and in addition sodium fluoride.
COMPOSITION
Illuminé home 10%:
Illuminé home 15%:
Both Illuminé home tooth whitening gels have pH values of approximately 6.0.
INDICATIONS
1. Tooth discolouration caused by:
• Staining from food, drinks and tobacco with penetration into the tooth substance• Age-dependent degenerative changes• Tetracycline (first and second grades) or minocycline medicamentation• Fluorosis, especially brown pigmentation• Pulp necrosis and/or endodontic treatment.
2. Masking of enamel modelling.
3. Genetically determined dark teeth.
4. Whitening of discoloured teeth prior to restorative and/or prosthodontic measures, e. g.
The best results are with patients whose teeth are discoloured to yellow, orange or lightbrown.
CONTRAINDICATIONS
1. Use during pregnancy or lactation.
2. Known allergy to hydrogen peroxide or other ingredients of the products.
3. Extrinsic stains which can easily be removed by professional tooth cleaning and which can be prevented by thorough oral hygiene.
4. Use in heavy smokers unless they refrain from smoking while wearing the tray.
WARNINGS
1. Illuminé home contains carbamide peroxide which may be irritating. Avoid contact
with oral tissues, eyes and skin. If accidental contact occurs, flush affected area withgenerous amounts of water. In case of contact with eyes, rinse immediately withplenty of water and seek medical advice.
2. Care should be taken to assure that the reason for the discolouration is understood, in order to avoid masking of pathological conditions.
PRECAUTIONS
Sensitivity of the teeth and gingival tissues may occur during the treatment.
For teeth sensitivity, try using slightly less Illuminé home tooth gel or shorten the length
of time for each exposure.
Particular care should be given during insertion of the tray to carefully remove excess
material as well as misapplied material from mucosal tissues and to avoid contact to
skin and eyes.
If discomfort or teeth ache is experienced for an extended period of time, please consult
your dentist for the next appropriate steps.
INTERACTIONS WITH DENTAL MATERIALS
Existing tooth coloured restorations may not match the lighter shade of teeth after the
treatment and may need to be replaced.
Illuminé home should be used before the placement of composites, veneers or crowns,
in order to maintain a close match of tooth colour.
Some old restorations (e.g. amalgams) may leave dark stains in the tray. This is normal
and harmless.
ADVERSE REACTIONS
Sensitivity of teeth and irritation of the oral mucosa may be experienced from the use of
carbamide peroxide-based products.
Irritation of the oral mucosa may occur. Sore throat or nausea may be experienced ifexcessive gel is swallowed. Remove excess gel after the insertion of the tray with fingeror toothbrush.
If sensitivity of teeth or irritation of the oral mucosa continue although all precautions havebeen met, discontinue use of the product and consult your dentist as soon as possible.
WHITENING APPLICATION GUIDE
1. Brush and floss teeth prior to wearing the tray.
2. Prior to first use of an Illuminé home syringe, replace cap by one of the applicators
3. Open applicator by breaking off tip (retain tip to close applicator after use of syringe).
4. Following your dentist´s instructions, place small amounts of gel towards the facial side of each tooth to be treated. DO NOT overfill the tray.
Close applicator on syringe and retain syringe for next treatment until empty. Eachsyringe contains approx. 3 to 5 applications.
5. Insert the gel tray in the mouth over the teeth. Wipe the excess material from the gum or tissue with your finger or toothbrush.
6. Wear the tray with gel throughout the night or as directed by your dentist (a minimum 7. Do not eat or drink anything or smoke while wearing the tray.
8. After treatment, remove tray and rinse your teeth. Brush away any remaining gel.
9. Clean the gel tray with warm water and a toothbrush. Dry thoroughly and store in the TREATMENT PERIOD
The usual treatment period is one to two weeks and ends when the desired tooth shade
is attained.
At your recall appointment with your dentist, the treatment results will be assessed.
In serve cases, an extended treatment time of from six weeks to six months may be
required to attain the desired effect.
Usually, the achieved results will last up to two years.
STORAGE
For long-term storage prior to use, refrigerate (2 - 8 °C) the gel to maintain shelf life and
assure the maximum effectiveness of the product. Keep the Illuminé home kit away
from heat or direct sunlight at all times.
BATCH NUMBER AND EXPIRY DATE
The batch number should be quoted in all correspondence which requires identification
of the product.
Do not use after expiry date.
If you have any questions, please contact your dentist.
Manufacturer:
Distributor:
DENTSPLY DeTrey GmbH
DENTSPLY Limited
De-Trey-Str. 1
Hamm Moor Lane
78467 Konstanz Addlestone, Weybridge
GERMANY Surrey KT15 2SE
Phone +49 (0) 75 31 5 83-0
Phone (0 19 32) 85 34 22
DENTSPLY DeTrey 2001-02-14

Source: http://www.dentsply.es/DFU/eng/Illumine_Home_Patient_eng.pdf