Ledermix Paste

/ Neopharm

– Cases of pulpitis with exposure of the pulp Use of Ledermix paste. Practical procedure: 1st session: If after preparing a cavity and creating the extension and retention element the removal of the carious dentine close to the pulp has resulted in exposure of the pulp, carefully clean the cavity and pulp wound (3% hydrogen peroxide or physiological saline solution). Press out a small amount of Ledermix onto a small pellet of cotton wool or felt and apply to the exposed pulp. Close the cavity with zinc-oxide eugenol or another tightly sealing temporary cavity filling material. 2nd session: (two to three days later): Vitality test. Remove the temporary filling and pellet. Clean the cavity and pulp wound (3% hydrogen peroxide or physiological saline solution). Inspect the pulp wound. Local anaesthesia if required. Cap the exposed pulp. Then perform underfilling and final cavity filling in the same session.
– Cases of pulpitis with closed pulp cavity. Since exposure of the inflamed pulp will endanger its vitality, it should be avoided if possible by applying the principles of indirect capping. Then place the final filling. The same approach as for pulpitis prophylaxis is recommended for “iatrogenic pulpitis”. Important note Suppression of the inflammatory mechanism by the corticoid is associated with a temporary reduction in the connective tissue activity of the pulp. It should therefore be ensured in case of exposed pulp that the water-soluble preparation Ledermix paste does not remain in contact with the dental pulp for too long (see under A above). If the water-soluble preparation is left in place uncontrolled or the temporary filling is not leak-tight, there is a risk of pulp death.
– Cases of periodontitis Both for primary acute periodontitis developing from total purulent pulpitis and for acute episodes of chronic periodontitis, prepare the canal as far as the apex in the first session (mechanical and chemical preparation: sodium hypochlorite, hydrogen peroxide), dry and fill with Ledermix paste using a spiral plugger (lentulo). In the second session (about 1 week later), rinse the Ledermix paste out of the canal (hydrogen peroxide) and complete the gangrene treatment using one of the recognised methods. For periodontitic irritations (especially following root canal widening) during the course of root treatment, introduce Ledermix paste into the cleaned root canal with rotating motion and leave in place for about 1 week. In the next session, remove Ledermix paste from the canal and after an inert temporary filling complete the root treatment.
Dosage: The dosage depends on the type and scope of use. Use in children (from 3 years old) has not been sufficiently studied. For safety reasons the use of this product in this age group should only be considered after a very rigorous risk-benefit assessment since the known systemic actions of glucocorticoids and tetracyclines cannot be reliably ruled out.
For full details see prescribing information.

Prophylactic pulpitis treatment. Conservative treatment of acute pulpitis (“pulpitis acuta”) while maintaining pulp vitality. Treatment of acute periodontitis (initiating root canal treatment in total purulent pulpitis and gangrene).

Known hypersensitivity to demeclocycline, triamcinolone acetonide, other corticoids or tetracyclines, sodium sulphite or one of the other ingredients, purulent pulpitis, root canal treatment of milk teeth.

In rare cases sodium sulphite may induce severe allergies and bronchial cramps (bronchial spasms). Important note: The corticoid contained in the water-soluble Ledermix® paste is released during the entire period of application. Due to the antiproliferative effect of all corticoids Ledermix® paste may not be left on the open pulpa for a longer period (e.g. 2 – 3 days) to avoid possible pulpa necrosis; potential development of a chronic pulpitis must also be taken into account (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 reducing healing capacity).

Immune system disorders: Very rare: cases of allergic reactions up to an anaphylactic shock may occur. Cross-allergies with other tetracyclines are possible. Sodium sulphite may, in rare cases, induce severe allergies and bronchial cramps (bronchial spasms).

Phenytoin, barbiturates, carbamazepine, aminoglutethimide, rifampicin. Thiazide and loop diuretics, cardiac glycosides, acetazolamide. Oral hypoglycemics, insulin, antihypertensives, anabolic steroids, ophthalmic idoxuridine. NSAIDs, aspirin, other salicylates, coumarin anticoagulants, vaccines, estrogens.

Ledermix paste should not be used during pregnancy or lactation. Use of Triamcinolone is inadvisable in the first five months of pregnancy is particular, since animal experiments have revealed evidence of  teratogenic effects, and no data have been collected on the safety of use in humans during this period. The possibility of intrauterine growth disorders cannot be excluded in long-term applications. Treatment at the end of pregnancy involves the risk of atrophy of the foetal adrenal cortex. Glucocorticoids pass into breast milk. Breast-feeding should be stopped if treatment with higher doses or a long-term therapy is required.  Demeclocycline penetrates the placenta membrane and is excreted into breast milk. Due to the antianabolic effect and teratogenic effects – including deposits in bones and teeth – demeclocycline should, if possible, not be used during pregnancy and lactation.

There were no reports of overdose. Overdoses are not to be expected because of the method of application and the very low absorption rate.