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

Conducted by: Centre of Therapeutic Dentistry, Department of Therapeutic Dentistry, Pavlov State Medical University of Saint Petersburg

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

Selected individuals: 100 diabetes (type 2) patients between the ages of 21 and 67 were divided into three main groups and one placebo-control group. Each group consisted of 25 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 status of periodontal tissues:

- Periodontal index (PI)

- PMA index (1967)

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

- WHO (World Health Organization) bleeding index with subsequent estimation of hemostatic efficiency

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

In the beginning of the study selected individuals were taught the oral hygiene rules. Subjects singly used combined technique to clean their teeth two times a day (in the morning and in the evening) within two minutes.

Dates: 2007, January-May

RESULTS

One month usage of DiaDent dentifrices proved their high efficiency (according to Fedorov-Volodkina hygiene index) in all groups, although the results showed different scores for diverse groups.

The first group (Toothpaste REGULAR) showed the highest cleaning efficiency (according to Fedorov-Volodkina hygiene index). The four-week index score was 66.67%.

The second group (Toothpaste ACTIVE) demonstrated the second best cleaning efficiency (according to Fedorov-Volodkina hygiene index). The four-week index score was 61.29%.

The placebo-control group showed comparatively low cleaning efficiency. The four-week index score was 57.78%.

The third group (Toothpaste SENSITIVE) demonstrated the lowest cleaning efficiency (according to Fedorov-Volodkina hygiene index). The four-week index score was 55.56%.

The first group showed the highest cleaning efficiency (according to Green-Vermillion index). The one-week index score was 38.09%.

The second group demonstrated higher cleaning efficiency than the first group after three weeks of study (47.37% in the first group and 52.38% in the second group).

The third group showed the lowest reduction in both hygiene indexes. The F-V index score was 40.74% and the G-V index score was 41.18%.

The placebo-control group demonstrated relatively higher scores (F-V index score was 44.45% and G-V index score was 46.15%).

A slight difference in the evaluated results of study in the first and second groups proved that DiaDent REGULAR Toothpaste effectively cleans the entire mouth cavity while DiaDent ACTIVE Toothpaste is more effective in the frontal part.

The evaluated results of cleaning efficiency varied according to different hygiene indexes because Fedorov-Volodkina index is used to estimate the condition of the frontal part of the mouth and Green-Vermillion index offers the possibility of evaluation of the hygiene condition in the whole mouth cavity.

The second group demonstrated the highest anti-inflammatory efficiency. The PI index scores were the highest in the second group in all periods of the study. The four-week index scores were 39.02% in the first group, 43.24% in the second group, 34.09% in the third group and 26.67% in the fourth group.

The PMA anti-inflammatory efficiency index scores at the end of the study were:

62.82% in the first group (DiaDent REGULAR Toothpaste) – the second best result;

68.74% in the second group (DiaDent ACTIVE Toothpaste) – the highest efficiency;

54.88% in the third group (DiaDent SENSITIVE Toothpaste) – the third result;

52.05% in the placebo-control group – the lowest efficiency.

The DiaDent ACTIVE Toothpaste demonstrated the highest hemostatic efficiency according to one-month WHO index score that was 76.47%. The DiaDent REGULAR and SENSITIVE Toothpastes showed the second best result (the hemostatic index scores were 66.67% in both groups) and placebo-control group demonstrated the lowest hemostatic efficiency (WHO index score was 54.54%).

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

CONCLUSION

The clinical trials of DiaDent dentifrices demonstrated that they possessed cleansing and anti-inflammatory effects, effectively removed dental plaque. It was proved by the reduction of periodontal indexes. Neither allergenic nor local irritant effects were observed during the study on patients with diabetes. DiaDent REGULAR Toothpaste possessed a significant cleansing effect while DiaDent ACTIVE Toothpaste had strong hemostatic and anti-inflammatory effect. DiaDent SENSITIVE Toothpaste and Placebo Toothpaste demonstrated the same hemostatic effect. The Placebo Toothpaste showed higher cleaning efficiency than DiaDent SENSITIVE Toothpaste.

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