Pharmaceutical product for the treatment of initial caries, hypersensitive tooth necks and for an intensive caries prophylaxis

elmex gel contains 12500 ppm (1.25%) fluoride, and is thus designed for use in intensive fluoridation. On the basis of EU guidelines, it is a pharmaceutical product. (IKS Nr. 34916) In some countries (Switzerland), it is an OTC product, while in others (such as the Netherlands) it is a prescription only medicine. In Germany this is depending on the package size.

Composition

elmex gel is a gel containing a high concentration of fluoride. It contains a total of 12500 ppm F-, 2500 ppm (0.25%) in the form of the amine fluorides Olaflur and Dectaflur, and the rest in the form of sodium fluoride (1%). elmex gel contains no abrasive cleaning agents, preservatives, or colorants. It has a pale yellow colour, and a fruity apple-banana flavour.



INCI name of ingredient		Function of ingredient



Active agents

Amine fluoride Olaflur		0,23 % F-

Amine fluoride Dectaflur		0,02 % F-

Sodium fluoride		1,00 % F-

Fluoride content (TOTAL)		1,25 % F-

Adjuncts

Aqua		Solvent

Propylene Glycol		Humectant

Hydroxyethylcellulose		Thickening agent

Aroma		Aroma and flavourings: e.g. apple-banana flavour, d,I-menthone, peppermint oil, spearmint oil (containing menthol)

Saccharin		Sweetener

pH: 4,8 (10 % in water)

elmex gel is a pharmaceutical gel containing amine fluoride which is designed for use in intensive caries prophylaxis, in the treatment of hypersensitive teeth and initial caries lesions.

Caries prophylaxis

for intensive caries prophylaxis in children and adults

for intensive caries prophylaxis in groups which are particularly at risk of developing caries, such as children/adolescents with orthodontic appliances or who are receiving orthodontic treatment, adults with bridges or partial prostheses, patients with xerostomia

Therapy

for the treatment of initial caries lesions

for the treatment and protection of hypersensitive teeth

Effects

Active ingredients in elmex gel are the amine fluorides olaflur and dectaflur. Sodium fluoride is used as an additional source of fluoride, as it is more neutral in flavour than the amine fluorides.

elmex gel protects the teeth over the long term from caries as

It forms an adhesive calcium fluoride layer, which

protects dental enamel against acid attack

reduces the acid solubility of dental enamel

represents a fluoride depot with a long life

resists mechanical abrasion

is resistant to being rinsed away by saliva

It provides rapid distribution of the active ingredients in the oral cavity, so that areas which are only accessible with difficulty, such as fissures, the areas between the teeth, and areas near orthodontic/prosthetic appliances, are effectively protected.

It inhibits bacterial growth, thus delaying formation of plaque

It inhibits bacterial acid production

elmex gel treats initial caries lesions by means of:

Stimulation of remineralisation

elmex gel and exposure of the dental neck

elmex gel reduces the hypersensitivity of exposed dental necks:

Use of elmex gel results in the formation of an adhesive calcium fluoride layer on dental enamel and dentine.

elmex gel creeps into the dentinal tubules to form calcium fluoride, which blocks the tubules.

The protective calcium fluoride layer is resistant to mechanical abrasion and to acid attack.

elmex gel is particularly efficacious in blocking the effects of the oral cavity milieu on the open dentinal tubules, which are responsible for the hypersensitivity of the teeth, over the long term.

elmex gel provides protection against dental neck and root caries:

Amine fluorides react with dental enamel and with dentine to form calcium fluoride. The anticariogenic effects of elmex gel also protect the caries-sensitive dentine.

elmex gel prevents abrasion and the development of wedge-shaped dental neck defects:

elmex gel hardens the material in the exposed dental neck, making it more resistant, so that it is protected against mechanical abrasion.

Use of elmex gel

Domestic dental care

Adults: Brush the teeth once a week for 2 minutes with approximately 0.5 g elmex gel. This quantity contains 6.25 mg fluoride. Then spit out, and rinse the mouth briefly.

elmex gel should be used by children aged 6–8 years under parental supervision only.

In groups with an increased risk of caries, e.g. individuals with orthodontic appliances or patients receiving chemotherapy with xerostomia, elmex gel may be used more often according to dentist's recommendation.

In schools

elmex gel is suitable as a fluoridation agent for use in class toothbrushing exercises as part of school caries prophylaxis programmes. Frequency of use will depend on organisational factors, but it should be used 6 - 12 times yearly. The method of application is as described above. The instructor should control the time of application (max. 2 minutes)

For targeted use in individuals with exposed dental necks, apply elmex gel with a soft brush or your finger to the affected areas of the teeth, and massage softly.

Tray application in high risk patients

Adults and children over the age of 8 years: A total of 6–8 g of elmex gel is applied in the oral cavity; this is equivalent to a fluoride dose of 75 - 100 mg. The patient should bend slightly forward and should not swallow the overflowing material. The patient should rinse the mouth after use. The gel should not be allowed to remain in contact with the teeth for longer than 3 to 5 minutes. Longer exposure time might increase the risk of mucosal irritations. The frequency of application follows the dentist's recommendation!

Please note that any statements regarding our medicinal products may vary slightly from country to country, depending on the requirements of the respective regulatory authorities.