GENGIGEL

HYALURONIC ACID

Restores Healthy Gums and Soothes Inflamed and Traumatised Oral Tissues

GENGIGEL is a medical device containing high molecular weight ( HMW ) hyaluronic acid ( in the form of sodium hyaluronate ), obtained by a biotechnological manufacturing process, which guarantees a high level of purity. Its formulation is specifically created in order to resemble that of the hyaluronic acid found in normal gingival tissue.

Hyaluronic acid is a naturally occurring physiological constituent of connective tissue ( especially in the gingival mucosa ), where it performs antioedematous and tissue repair functions. The physico-chemical and macro aggregating properties of hyaluronic acid helps to explain it's antiinflammatory properties.

HMW hyaluronic acid is found in connective tissue throughout the body in a selective and specific manner. It is particularly concentrated in the outermost layers of healthy gingival tissue where it contributes to both the barrier function and tensile strength of the periodontal ligament. The presence of HMW hyaluronic acid is essential for the maintenance of the healthy gingival tissue.

In periodontal disease and other tissue traumas ( inflammatory conditions, gingival pockets, wounds etc ) the tissue requirement for hyaluronic acid increases considerably ( by up to some 200% compared with the basal values ), thus demonstrating its specific role in regulating cell turnover and optimising local tissue regeneration.

The deficiency in hyaluronic acid that arises under these conditions prevents the tissue from :

* Restoring the normal free water balance ( as a consequence of which swelling and compression causes an increase in pain ).

* Activating the migration of fibrocytes ( cells contributing to tissue healing ) and as a consequence healing is delayed.

Therefore the lack of suitable HMW hyaluronic acid is responsible for the continuation of the inflammatory condition.

Studies in man show that the availability of exogenous hyaluronic acid of similar characteristics to that of the naturally occurring component helps to facilitate the natural tissue healing and recovery process.

GENGIGEL is therefore an innovative product providing long acting biotechnologically manufactured hyaluronic acid of High Molecular Weight. Application of hyaluronic acid provides periodontal tissue/fluid balance with accelerated healing and repair functions by preventing the deficiency of natural gingival HMW hyaluronic aid and enhancing its effects. Hyaluronic acid does not develop and local or systemic pharmacological effect upon the mucosa. Hyaluronic acid is extensively depolymerised and reduced to its basic sub-unit constituents by plaque bacterial enzyme action.

GENGIGEL provides maximum adhesion and thus allows hyaluronic acid ( which would otherwise be eliminated by constant salivary drainage ) to remain in situ.

GENGIGEL is extremely safe presenting no contraindications or side effects and can be used without restriction by children, pregnant women and the elderly. The GENGIGEL safety profile is particularly useful when anti-inflammatories are contraindicated. By virtue of the properties of Xylitol, a natural sweetener that does not promote tooth decay or cause significant variations in the blood sugar level, the product is also suitable for diabetics. It does not have any known drug interactions so it may be safely used during specific therapies; e.g. with antibiotics.

Indications : Inflammatory conditions ( gingivitis, gingival bleeding, gingival retraction, gingival pockets ), other tissue trauma ( abrasion, tooth extractions, post-surgical recovery etc. ) and those disease conditions where the gingival mucosa requires increased concentrations of hyaluronic acid.

Directions for use : After correct oral hygiene apply GENGIGEL three to five times a day ( after main meals ) for 3-4 weeks, continuing until all symptoms have disappeared.

Gel : Apply a film of gel onto the gingival tissue massaging gently with clean fingers to aid its correct distribution on the mucosal surface.

Liquid : Rinse with 10ml ( one dose ) for 1-2 minutes. The compound is ready for use; do not dilute.

Spray : Any puff guarantees a homogeneous and constant distribution of liquid on the mouth surface; 1 or 2 puffs on the inflammatory or traumatised tissue. Keep the bottle vertical.

Warnings : Confirmed individual hypersensitivity to the constituents of the formulation. Should the symptoms persist, consult a healthcare professional. Store at a temperature of 5^oC - 40^oC.