Results of the trials

Caries intensity (CPR) for the examined patients was 9.6 + 0.03, constants’ values as follows: “C” – 1.2 + 0.004, “P” – 7.9 + 0.001, “R” – 0.5 + 0.001. All the patients are referred to the group of decompensated dental status which obviously speaks for the need to optimize and intensify their mouth hygiene as well as to expand the range of mouth hygiene aids, recommended to these patients.

The original hygiene index (HI) was 1.8 + 0.001 balls. It remained unchanged for the patients who were maintaining mouth hygiene by traditional means. For those who were using the anti-cavity mouthwash it was 1.2 + 0.002 balls, the difference is statistically reliable (p<0.01).

The original papillary-marginal-alveolar index (PMA) was 26.9 + 0.01 %. It remained unchanged for the patients who were maintaining mouth hygiene by traditional means. For those who were using the anti-cavity mouthwash it was 9.3 + 0.2%, the difference is statistically reliable (p<0.01).

The index of natural colonization of buccal epithelium (ICBE).

The trials showed fluctuation of the ICBE rate caused by microorganisms with both patients who were not using and who were using the anti-cavity mouthwash for their mouth hygiene, ICBE = 112 + 11.7 (4 balls) and ICBE = 69 +5.9 (3 balls) respectively. ICBE shows the clinical pattern of a patient’s mouth cavity condition because it changes depending on the dental status which in turn is bly influenced by the quality of mouth hygiene .

The coefficient of local immunity factors balance in the mouth cavity.

The lysozym activity with patients of 21 years old was 30.0 + 9.0%, while after they applied the anti-cavity mouthwash it significantly increased up to 53.0 + 1.5%, the difference is statistically reliable (p<0.05). The figures clearly indicate that the anti-cavity mouthwash has a positive effect on the lysozym activity change, restoring its activity rate. The amount of lysozym typical of a decompensated mouth health level is lower as compared to that of a healthy mouth cavity. It is with groups showing a decompensated form of caries that the increase of lysozym activity, and the non-specific mouth protection accordingly, was most considerable after administration of the anti-cavity mouthwash equaling to 43%. The lysozym activity went up by 1.8 times, as compared to the original, with the 21-year-old patients under examination.

The amount of sIgA.

With CPR = 5 and higher the amount of sIgA before and after administration of the anti-cavity mouthwash by the 21-year-old patients was 0.313 + 0.003 g/l and 0.453 + 0.015 g/l respectively, the difference is statistically reliable (p<0.01). The amount of sIgA in the mouth liquid of the patients having a decompensated form of caries, CPR = 9.6 + 0.03, was 2 times less than the normal one. With the caries intensity = 5 and higher and unsatisfactory mouth cavity hygienic condition, the amount of sIgA for all age groups was significantly below the norm. A month after the patients had a professional cleaning of teeth, were taught to maintain the mouth hygiene properly and started using the anti-cavity mouthwash, the amount of sIgA increased for all the patients equaling 0.453 + 0.015 g/l, while the original one was 0.313 + 0.003 g/l, the difference is statistically reliable (p<0.01). According to the results of the local immunity condition examination before and after administration of the anti-cavity mouthwash, 49.2% out of 64 patients had weak mouth immunity, 36.4% - had moderately weak mouth immunity, and just 14.4% had a good coefficient of local immunity factors balance in the mouth cavity. After a 1.5 months use of the anti-cavity mouthwash , the coefficient of local immunity factors balance improved to 19.7% (by 2.5 times better), 41.7% (by 0.9 times better) and 38.6% (by 3 times better) respectively.

The committee members noted the positive properties of the anti-cavity mouthwash offered for the clinical trials:

An excellent therapeutic effect of the anti-cavity mouthwash.

1. The anti-cavity mouthwash has a pleasant presence noted by both patients and dentists.

2. The anti-cavity mouthwash has a stable transparency, nice smell and taste.

3. A high hygienic level – the HI according to the Green-Vermillion index = 1.2 + 0.002 balls. The patients in particular note a comfortable sensation in their mouths which was created by the use of the anti-cavity mouthwash which optimizes and intensifies the mouth hygiene ritual .

4. The anti-cavity mouthwash has an anti-inflammatory effect which is asserted by the negative Schiller-Pisarev assay and a significant increase of the PMA index as well as by a considerable relief of hyperemia and hypostasis of the tissues surrounding teeth.

5. The anti-cavity mouthwash has a hemostatic effect which is asserted by a relief or a complete elimination of angiostaxis.

6. Improvement of the dental status is identified by the increase of the PMA index as well as by the decrease of ICBE and the increase of the coefficient of local immunity factors balance in the mouth cavity.

7. The coefficient of local immunity factors balance in the mouth cavity has become better. The anti-cavity mouthwash stimulates lysozym activity and increases the sIgA activity. They have increased by 2.5 times with the patients with weak immunity, by 0.9 times with the patients with moderately weak immunity and by 3 times with the patients with a good coefficient of local immunity factors balance.

8. The anti-cavity mouthwash has a good tolerance and does not cause any topical or systemic allergic reactions.

Nevertheless, the committee finds it necessary to pose several questions which do not demolish the value of the anti-cavity mouthwash offered for the clinical trials:

1. What is the expiration date of the anti-cavity mouthwash?

2. What is the period of application of the anti-cavity mouthwash?

We think it necessary to suggest further work on the design of the bottle and the 20-25 ml dosing cap.

CONCLUSION:

The clinical trials of the new anti-cavity mouthwash identify the fact that the children and adults in Russia now can enjoy a home-produced mouth hygiene aid which has a high therapeutic effect and deserves dentists’ attention.