CLINICAL TRIALS DiaDent REGULAR Toothpaste (DiaVit® product group) DiaDent REGULAR Mouthwash (DiaVit® product group) DiaDent ACTIVE Toothpaste (DiaVit® product group) DiaDent ACTIVE Mouthwash (DiaVit® product group) on patients with diabetes (type 2)

Conducted by: Diabetic Dental Care Centre, City Dental Clinic №7, Samara

Purpose of the research: evaluation of the effects claimed by the manufacturer:

- Cleaning effect;

- Anti-inflammatory effect;

- Hemostatic effect;

- No local irritant and allergenic effects

Selected individuals: 90 diabetes (type 2) patients between the ages of 35 and 65 were divided into two main groups and one placebo-control group. Each group consisted of 30 people.

Materials and Methods:

Following indexes were used to evaluate the cleaning effect:

- Fedorov-Volodkina Hygiene Index

- Green-Vermillion Hygiene Index (OHI-S)

Following indexes were used to estimate the inflammation status of periodontal tissues:

- Gingivitis Index (GI)

- PMA index

Following index was used to estimate the intensity of gum bleeding:

- WHO Bleeding Index with subsequent estimation of hemostatic efficiency

Potential local irritant and allergenic effects were studied during the whole research.

Dates: 2011, April-September

RESULTS

1. DiaDent REGULAR Toothpaste and Mouthwash possessed the most powerful cleaning effect according to the OHI-S (Green-Vermillion) and Fedorov-Volodkina hygiene indexes.

2. DiaDent REGULAR Toothpaste and Mouthwash were proved to be effective in the anterior area and in the whole mouth cavity at single use.

3. DiaDent ACTIVE Toothpaste and Mouthwash were pointed out to have strong anti-inflammatory effect that was observed during the whole clinical trials period.

4. DiaDent ACTIVE Toothpaste and Mouthwash possessed significant hemostatic effect.

5. DiaDent REGULAR and ACTIVE dentifrices did not have allergenic or local irritant effect on oral mucosa of patients with diabetes.

CONCLUSION

The clinical trials proved cleansing and anti-inflammatory effects of DiaDent dentifrices as well as their efficacy in plaque removal. It was established by the reduction of periodontal indexes. DiaDent REGULAR Toothpaste had a significant cleansing effect while DiaDent ACTIVE Toothpaste and Mouthwash had strong hemostatic and anti-inflammatory effect.

Neither allergenic nor local irritant effects were observed during the study on patients with diabetes.

All Toothpastes and Mouthwashes studied in the research demonstrated their benefits for patients with serious general disease - diabetes.