SOP - BASIC HAZARD SPOTTING / RISK ASSESSMENT DATE: 27th February 2017

DEPARTMENT Restorative DRAFTING SOP: SUBSTANCE Inside/Outside Non Vital Bleaching with Illumine INDICATIONS: External vital bleaching/Inside-outside non-vital bleaching PRESENTATION: 3 ml. syringe containing 15% carbamide peroxide FORMULATION: Form: Gel Colour: Clear Illumine comes as 15% tooth whitening gel. 15% carbamide peroxide, releasing H₂O₂ (the active ingredient) at a concentration of about 5.4% in addition to sodium fluoride. PROPERTIES: Illumine gel is a clear bleaching agent which can have a minty taste. Carbamide peroxide can be an irritant (if it comes into contact with gingival and mucous membranes. INSTRUCTIONS FOR External Bleaching USE: - Take a pre-operative shade (ideally with a photograph and shade tab) - Record the illumine gels concentration, batch number and expiry date in the patients chart - Insert the tray (s) and ensure a good fit, especially at the gingival margins - Demonstrate to the patient how to load and insert the trays - Ensure the patient doesn’t overfill the tray with bleaching agent and show them how to remove excess - Advise to reduce use to every second day if teeth become sensitive - If sensitivity becomes unbearable, advise the patient to discontinue use and make and appointment with you. Inside/Outside Bleaching - Take a pre-operative shade (ideally with a photography and shade tab) - Apply rubber dam if Gutta Percha will be exposed - Remove all of the restorative material in the access cavity to 2-3 mm below the CEJ. Ensure a 2 mm GIC plug seals the gutta percha and mimics the contour of the CEJ. - Insert the tray(s) and ensure a good fit, especially at the gingival margins - Demonstrate to the patient how to load and insert the tray for the tooth/teeth undergoing internal bleaching only - Ensure the patient doesn’t overfill the tray with bleaching agent and show them how to remove excess - Instruct the patient on cleaning the access cavity after eating with Tepe brush/mouthrinse LIST THE HAZARDS: 1. Patients should always be warned of the potential sensitivity of the teeth and gingival tissues during the treatment. 2. Treat any uncared for caries and repair edge gaps in existing restorations, enamel gaps or cracks and free-lying regions of dentine, prior to whitening, to reduce the probability of the material reaching the pulp, resulting in hypersensitivity or in am- matory reaction. 3. Avoid exposure of known hypersensitive teeth and teeth with expanded pulp cavities to the whitening agent. 4. Assure trays are properly fitted to reduce the probability of swallowing the material, reduce the quantity of material required and avoid gingival contact. 5. 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. 6. If a patient experiences discomfort or sensitivity of the teeth or gingiva during treatment with Illuminé home, the following is recommended: Patient should contact dentist for advice on appropriate steps to be taken. For teeth sensitivity, try using slightly less Illuminé home gel or shorten the length of time for each exposure. Apply a topical fluoride gel by following the directions of the manufacturer. For gingival sensitivity, be sure the gel tray is not rubbing against the marginal gingiva. Additional trimming of tray may be necessary. RISK:  Illuminé home contains carbamide peroxide which may be irritating. Avoid contact with oral tissues, eyes and skin. If accidental contact occurs, flush affected area with generous amounts of water. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.  Care should be taken to assure that the reason for the discolouration is understood, in order to avoid masking of pathological conditions.  Keep out of reach of children. WHO MIGHT BE Staff, patients and students. HARMED: RISK ADEQUATELY Yes CONTROLLED? SPECIAL In case of skin/ginigival contact: Rinse gingiva/skin with water for WARNINGS & 10 minutes. If symptoms do not subside, seek medical attention. PRECAUTIONS: Retain unused bleaching agent for future use or dispose of in clinical waste bin. STORAGE: Protect from light in closed contained. Keep lid on the delivery tip.