Elgydium Clinical Study 3

Authors: A Daniel, J J Potherat, J C Vezin

Publication: Le Chirurgien-Dentiste de France, 26th February 1987, No. 370

Title: Study of the clinical activity of a toothpaste containing chlorhexidine in daily oral dental hygiene (after scaling)

Summary:

The study involved three groups of 40 patients, none of whom presented with a pathology necessitating the taking of medicine with an antibacterial or anti-inflammatory action.  The subjects did not rinse their mouths after brushing (they simply spat out the excess toothpaste present in the mouth so as not to swallow it) in order not to eliminate the active principle, conforming to the normal directions for use of a pharmaceutical toothpaste.  After undergoing preliminary scaling and receiving a standard toothbrush, the subjects were divided up randomly into one of the three following groups:

Group 1 ­ for one week, no usual oral dental hygiene was carried out
Group 2 ­ for one week, usual oral dental hygiene was carried out using the toothpaste tested without chlorhexidine (placebo group)
Group 3 ­ for one week, usual oral dental hygiene was carried out using the toothpaste with chlorhexidine.  The toothpaste contained 4000ppm of active principle.

On Day 0 and Day 7, the plaque index and the gingival index were measured.

1. The cessation of any oral-dental hygiene for one week caused considerable accumulation of plaque and at the same time the development of a clinically detectable gingival inflammation (erythema, edema, bleeding gums) could be observed.

2. The use under usual conditions of a toothpaste without any active principle but with a new toothbrush enabled the accumulation of plaque and the development of a gum inflammation to be effectively controlled.

3.T he use under usual conditions of the toothpaste containing chlorhexidine potentialized the effect of the mechanical control exerted by the toothbrush with regard to the accumulation of bacterial plaque and especially with regard to gingival inflammation, which confirms the findings of numerous studies throughout the world on the efficacy of chlorhexidine in dental hygiene.

4. No secondary effect linked to the presence of chlorhexidine was detected in Group 3, which shows that the concentration of the active principle did not reach a level likely to cause secondary effects such as dental colourations which occurred in higher concentrations.