BACKGROUND/AIMS: A healthy mouth harbours the continuous combined action of a salivary defence system with that of a salivary peroxidase system, containing lactoferrin, lysozyme, immunoglobulin and growth factors. This system maintains neutral pH and creates an oral environment where harmful bacteria are inhibited, thus preventing the formation of biofilms. The objective of this clinico-microbiological trial was to evaluate the anti-plaque effect of a dentifrice containing salivary substitutes, compared with a placebo-control dentifrice and to assess the effect of dentifrice on oral bacterial count. METHODS: The design was a randomized controlled, double-blind, parallel study comparing a placebo-dentifrice to a dentifrice formulation containing salivary substitutes. Toothpaste slurry rinses were used over a 96-h period by 20 volunteers who refrained from all other oral hygiene procedures. Commercially available fluoride toothpaste was used as control. Plaque was scored and unstimulated salivary samples were collected at day 0 and after 4 days. A microbiological analysis was carried out for the salivary samples. Data were analyzed by using Student's t-tests. RESULTS: There was a statistically significant mean difference in plaque scores after using test paste (1.19 + 0.31) in comparison with those using placebo toothpaste (1.95 + 0.33). The difference between mean increase in colony forming units for the test and the placebo group was (25.2 + 8) x 10(5) and (17.5 + 6.01) x 10(5), respectively, which was statistically significant. CONCLUSIONS: The findings of the study support the hypothesis that toothpaste containing salivary substitutes prevents dental biofilm formation and exhibits antimicrobial property when compared with a placebo dentifrice.
RCT Entities:
BACKGROUND/AIMS: A healthy mouth harbours the continuous combined action of a salivary defence system with that of a salivary peroxidase system, containing lactoferrin, lysozyme, immunoglobulin and growth factors. This system maintains neutral pH and creates an oral environment where harmful bacteria are inhibited, thus preventing the formation of biofilms. The objective of this clinico-microbiological trial was to evaluate the anti-plaque effect of a dentifrice containing salivary substitutes, compared with a placebo-control dentifrice and to assess the effect of dentifrice on oral bacterial count. METHODS: The design was a randomized controlled, double-blind, parallel study comparing a placebo-dentifrice to a dentifrice formulation containing salivary substitutes. Toothpaste slurry rinses were used over a 96-h period by 20 volunteers who refrained from all other oral hygiene procedures. Commercially available fluoride toothpaste was used as control. Plaque was scored and unstimulated salivary samples were collected at day 0 and after 4 days. A microbiological analysis was carried out for the salivary samples. Data were analyzed by using Student's t-tests. RESULTS: There was a statistically significant mean difference in plaque scores after using test paste (1.19 + 0.31) in comparison with those using placebo toothpaste (1.95 + 0.33). The difference between mean increase in colony forming units for the test and the placebo group was (25.2 + 8) x 10(5) and (17.5 + 6.01) x 10(5), respectively, which was statistically significant. CONCLUSIONS: The findings of the study support the hypothesis that toothpaste containing salivary substitutes prevents dental biofilm formation and exhibits antimicrobial property when compared with a placebo dentifrice.