LEDERMIX FOR DENTAL USE

Adults:

Pulpitis: In all instances of exposed pulp and in acute pulpitis (except total purulent pulpitis), Ledermix paste is applied with a small cotton pledget to the dentine adjacent to the pulp or to the exposed pulp. The cavity is then closed with a temporary dressing such as zinc oxide- eugenol.

Approximately three to six days later, the vitality of the tooth is determined, the cavity is reopened and the cotton pledget is removed. The dentine close to the pulp, or the wound in the pulp, is covered with Ledermix cement prepared in the following manner.

To one drop of the hardener (no more), add sufficient Ledermix cement powder to obtain a homogenous mixture of cream-like consistency. This cement, which hardens rapidly, may be applied with an amalgam plugger or blunt probe. In small cavities with small areas of pulp exposure, Ledermix cement suffices as a base.

In larger cavities or more extensive pulp exposure, it is advisable to use Ledermix cement as a lining cement only and then to cover it with a structural layer of zinc phosphate or zinc oxide-eugenol cement before inserting the permanent restoration.

In certain instances of hyperaemia and partial serious pulpitis with closed pulp cavity, the use of Ledermix paste may be eliminated with Ledermix cement mixed with the hardener) applied in the first treatment period. However, as a general rule, and particularly in acute pulpitis and in teeth where the pulp is exposed, the prepared Ledermix cement should not be applied without previous treatment with Ledermix paste.

Pulp vitality should be monitored regularly.

Periapical periodonitis:

In primary acute periapical periodontitis and acute exacerbations of chronic periapical periodonitis, the canal may be prepared to the apex at the first sitting. After irrigation, the canal may be filled completely with Ledermix paste and sealed.

This treatment can be repeated if necessary on the follow-up visit about one week later, or the canal may be irrigated to remove the paste and further treatment carried out according to one of the generally accepted methods. If an alveolar abscess is present, drainage should be effective before beginning treatment with Ledermix.

Modern clinical data required to determine the frequency of undesirable effects are lacking for LEDERMIX. LEDERMIX is administered locally into the tooth cavity. However the various constituents are leached from the site of application in minute quantities over a long period of time.

There is therefore the potential for systemic side effects. 4) It has been suggested that in certain situations pulpal necrosis may occur. It is therefore advisable to monitor pulp vitality regularly and carry out endodontic treatment as appropriate.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Precautions:

The suppression of the inflammatory process by the use of a corticosteroid may result in a temporary reduction of the resistance of the pulp to infection and a reduced healing capacity. Therefore, Ledermix Paste should not be in contact with the exposed pulp for too long.

If the application of this water-soluble preparation is uncontrolled, or if the temporary dressing fits loosely, the danger exists that the pulp may not survive. The tip of the Ledermix Paste tube should always be kept clean and tightly closed after use.

Store in a cool place. The Ledermix Cement vial must be kept tightly closed after use. If severe reactions or idiosyncrasies are encountered, the restoration should be removed and appropriate measures instituted. Tooth discolouration has been reported during in vitro studies in animal or human teeth filled with Ledermix.

This may be exacerbated by exposure to light and prolonged tooth contact with Ledermix. Darkening/grey brown discolouration has also been reported in a study in humans after Ledermix use following avulsion and replantation of teeth.

This should be taken into consideration when treating visible teeth. In vitro studies have shown that the active ingredients demeclocycline and triamcinolone are degraded by admixture with calcium hydroxide powder and calcium hydroxide 40% paste in a 50:50 ratio by weight.

Ledermix Paste should not be mixed with calcium hydroxide prior to application. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Ledermix is contra-indicated in: • instances of total purulent pulpitis • patients hypersensitive to any of the ingredients of Ledermix • children under the age of 12 years.