Presentation and Status in Health Basket
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PERIODONTAL INSERTS 20 X 2.5 mg |
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Dosage
Adults including the elderly: Following mechanical debridement, a PerioChip is placed in each of the periodontal pockets to be treated. One PerioChip is inserted into a periodontal pocket with probing pocket depth (PD) 5 mm or greater. Up to 8 chips may be inserted in a single visit. Retreatment with PerioChip following mechanical plaque removal at 3 month intervals may provide additional benefit if pocket depth remains ³ 5mm.
The PerioChip biodegrades in the periodontal pocket over about a 7-day period and no return visit to the dental clinic to remove the periodontal insert is necessary. The patient should be instructed to continue normal oral hygiene procedures. No restrictions on dietary habits are needed.
Children and adolescents: PerioChip is not indicated in children and adolescents, since data on safety and efficacy in this age group have not been established.
Method of administration
Isolate the periodontal pocket and dry the periodontal pocket and the surrounding area. Open a blister cavity containing one PerioChip. Pick up the periodontal insert with a pair of forceps so that the rounded end points away from the forceps. Rapidly insert the periodontal insert, curved end first, into the periodontal pocket to its maximum depth and release. The periodontal insert can be further manoeuvred into position using the tips of the forceps or a flat plastic instrument. After proper insertion, PerioChip should rest subgingivally at the base of the pocket.
PerioChip insertion into periodontal pockets is rapid. The periodontal insert’s consistency allows placement into the pocket with little discomfort to the patient.
In the unlikely event of PerioChip dislodgement, several actions are recommended, depending on the day of PerioChip loss. If dislodgement occurs 7 days or more after placement, the dentist should consider the subject to have received a full course of treatment. If dislodgement occurs within 48 hours after placement, a new PerioChip should be inserted. If dislodgement occurs more than 48 hours after placement, the dentist should not replace the PerioChip, but reevaluate the patient at 3 months and insert a new PerioChip if the pocket depth has not been reduced to less than 5 mm.
Indications
Reduction and/or elimination of pathogenic periodontal pocket microbiota, delaying and/or arresting recolonization of the subgingival microflora, reduction and/or elimination of inflammatory lesions in the periodontal pockets, and as an adjunct to mechanical treatment in Periodontitis.
Contra-Indications
Hypersensitivity to chlorhexidine digluconate or to any of the excipients.
Special Precautions
There have been individual reports of systemic hypersensitivity following placement of PerioChip. Local hypersensitivity reactions such as gingival swelling are common.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving products containing chlorhexidine. These usually occur from within minutes to a few hours of dosing.
Patients should therefore be instructed to seek immediate medical attention if they develop allergic symptoms such as skin rash, itch, generalised swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhoea after exposure to chlorhexidine.
Side Effects
Approximately one third of patients experience adverse reactions, usually transient, during the first few days after chip insertion. These may also be due to the mechanical placement of the periodontal insert in the periodontal pocket or as a result of the preceding scaling procedure. The most commonly reported adverse drug reactions: Toothache, Gingival swelling, gingival pain, gingival bleeding.
Drug interactions
Chlorhexidine is known to be incompatible with anionic agents which may be present in some toothpastes and with sucrose in the diet. Such interactions do not impact significantly on the efficacy of PerioChip. Treatment remained effective with PerioChip during clinical studies in which patients continued with regular tooth brushing and their normal diet.
Nystatin is known to be antagonistic to the efficacy of chlorhexidine. Concomitant use of medicinal products containing this active substance should be avoided.
Pregnancy and Lactation
There are no data or limited data (less than 300 pregnancies) on the use of chlorhexidine in pregnant women.
Studies in animals have not shown any direct or indirect harmful effects (under normal conditions of use) on reproduction.
As a precaution PerioChip should be avoided during pregnancy.
Breast-feeding
It is not known if chlorhexidine is excreted in human milk.
A risk for newborns/infants cannot be excluded.
PerioChip should not be administered to nursing women.
Fertility
Studies in animals have not shown any effect on fertility (within normal conditions of use).
Overdose
No case of overdose has been reported.