BACKGROUND/AIMS: The use of specific antimicrobial agents in toothpastes may help reduce plaque and gingivitis. There would also appear to be some value in formulating products that contain combinations of such agents that may potentiate any activity present. The aims of this exploratory and pragmatic study were twofold: (1) Exploratory: to compare the effects on plaque re-growth of two zinc citrate/triclosan formulations, one of which contained bromochlorophene and hence demonstrate any additional beneficial effects produced by the addition of the phenol. (2) Pragmatic: to assess whether both pastes were significantly better than a benchmark control, proprietary fluoride toothpaste at inhibiting plaque formation. METHODS: Following an initial prophylaxis to remove all plaque and calculus, toothpaste slurry rinses were used over a 96 h period by 24 volunteers, while omitting all other oral hygiene procedures. After 24, 48 and 96 h, plaque was measured by plaque area and by plaque index. For comparative purposes, a conventional commercial fluoride toothpaste rinse was also used as a benchmark control in this triple cross-over double-blind study. RESULTS: With one exception, comparisons between the three pastes failed to show any significant differences in plaque accumulation at 96 h whether assessed by plaque index or area. At this time period, significantly more plaque was seen with the zinc citrate paste without bromochlorophene, compared with that of the control paste. CONCLUSIONS: The findings from this study failed to demonstrate a plaque-inhibitory action from the two novel formulations beyond that of a conventional benchmark toothpaste, although overall levels of plaque formed by the volunteers, especially on the control paste were generally lower than in previous studies. Nevertheless, it remains to be determined whether the test formulations could exert a direct anti-inflammatory action against gingivitis by way of the triclosan delivery system. Neither test formulation was subsequently marketed.
RCT Entities:
BACKGROUND/AIMS: The use of specific antimicrobial agents in toothpastes may help reduce plaque and gingivitis. There would also appear to be some value in formulating products that contain combinations of such agents that may potentiate any activity present. The aims of this exploratory and pragmatic study were twofold: (1) Exploratory: to compare the effects on plaque re-growth of two zinc citrate/triclosan formulations, one of which contained bromochlorophene and hence demonstrate any additional beneficial effects produced by the addition of the phenol. (2) Pragmatic: to assess whether both pastes were significantly better than a benchmark control, proprietary fluoride toothpaste at inhibiting plaque formation. METHODS: Following an initial prophylaxis to remove all plaque and calculus, toothpaste slurry rinses were used over a 96 h period by 24 volunteers, while omitting all other oral hygiene procedures. After 24, 48 and 96 h, plaque was measured by plaque area and by plaque index. For comparative purposes, a conventional commercial fluoride toothpaste rinse was also used as a benchmark control in this triple cross-over double-blind study. RESULTS: With one exception, comparisons between the three pastes failed to show any significant differences in plaque accumulation at 96 h whether assessed by plaque index or area. At this time period, significantly more plaque was seen with the zinc citrate paste without bromochlorophene, compared with that of the control paste. CONCLUSIONS: The findings from this study failed to demonstrate a plaque-inhibitory action from the two novel formulations beyond that of a conventional benchmark toothpaste, although overall levels of plaque formed by the volunteers, especially on the control paste were generally lower than in previous studies. Nevertheless, it remains to be determined whether the test formulations could exert a direct anti-inflammatory action against gingivitis by way of the triclosan delivery system. Neither test formulation was subsequently marketed.