Gengigel gel

Gengigel gel 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.

Gengigel gel indicated to treat inflammatory conditions (gingivitis, gingival bleeding, gingival retraction, gingival pockets) and other traumatic conditions (in particular mouth ulcers, wounds caused by removable prostheses or orthodontic appliances, cleaning, abrasions, tooth extractions, post-surgical recovery, etc.), and those disease conditions where the gingival mucosa requires increased concentrations of hyaluronic acid.

Hyaluronic acid is a naturally occurring physiological constituent of connective tissue (especially in the gingival mucosa), where it performs anti-oedematous and tissue repair functions.

The physico-chemical and macro-aggregating properties of hyaluronic acid help to explain its anti-inflammatory 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 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 optimizing local tissue regeneration.

The hyaluronic acid deficiency 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), as a consequence of which healing is delayed.

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

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

Gengigel gel is therefore an innovative product providing long-acting biotechnologically manufactured hyaluronic acid with high molecular weight. The application of hyaluronic acid provides a periodontal tissue/fluid balance with accelerated healing and repair functions by preventing the deficiency of natural gingival HMW hyaluronic acid and enhancing its effects. Hyaluronic acid does not develop any local or systemic pharmacological effects on the mucosa. Hyaluronic acid is extensively depolymerised and reduced to its basic sub-unit constituents by plaque bacterial enzyme action.

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

Gengigel gel is extremely safe, presenting no contraindications or side effects, and can be used without restriction by children, pregnant women and the elderly. The safety profile of Gengigel gel 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.

Directions for use

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

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

It is advisable not to eat or drink for at least 30 minutes after application.

Harmless if swallowed.

Warnings

confirmed individual hypersensitivity to the constituents of the formulation. Should the symptoms persist, consult a healthcare professional.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.