OBJECTIVE: In previous investigations the chlorhexidine (CHX) chewing gums tasted unpleasant. The main problem with different CHX formulations is the high incompatibility of CHX with anionic compounds. The purpose of this study is to introduce a new formulation for CHX gum that gives both anti-plaque effectiveness and an acceptable taste. DESIGN: Randomized, double blind, placebo-controlled crossover trial, employing two 5-day trial periods without mechanical oral hygiene. PARTICIPANTS: 18 from 22 volunteer dental students (8 males, 10 females, mean age 22 +/- 2.3 years). INTERVENTION: Active gum, containing 10 mg CHX, and placebo were used for 20 min twice daily. A 7-day washout period between trial periods was used. MAIN OUTCOME MEASURES: Turesky modification of the Quigley and Hein index was used to assess plaque formation. Success of blinding was assessed at the second day of each test period. At the end of each test period, subjects were asked to evaluate the taste of the products used. RESULTS:CHX gum has a significantly higher anti-plaque effect than placebo (95% confidence interval 2.7865 to 3.5302, p < 0.0001). Subjects could not determine the study drug assignment by taste or otherwise (p = 0.6250). The difference between subjective evaluations of the taste of chewing gums was not significant (p = 0.5879). CONCLUSION:CHX can be successfully incorporated in a chewing gum-based delivery system for use as an adjunct to or even short-term replacement for mechanical plaque control. The observation period needs to be extended if this product is anticipated for longer-term use.
RCT Entities:
OBJECTIVE: In previous investigations the chlorhexidine (CHX) chewing gums tasted unpleasant. The main problem with different CHX formulations is the high incompatibility of CHX with anionic compounds. The purpose of this study is to introduce a new formulation for CHX gum that gives both anti-plaque effectiveness and an acceptable taste. DESIGN: Randomized, double blind, placebo-controlled crossover trial, employing two 5-day trial periods without mechanical oral hygiene. PARTICIPANTS: 18 from 22 volunteer dental students (8 males, 10 females, mean age 22 +/- 2.3 years). INTERVENTION: Active gum, containing 10 mg CHX, and placebo were used for 20 min twice daily. A 7-day washout period between trial periods was used. MAIN OUTCOME MEASURES: Turesky modification of the Quigley and Hein index was used to assess plaque formation. Success of blinding was assessed at the second day of each test period. At the end of each test period, subjects were asked to evaluate the taste of the products used. RESULTS:CHX gum has a significantly higher anti-plaque effect than placebo (95% confidence interval 2.7865 to 3.5302, p < 0.0001). Subjects could not determine the study drug assignment by taste or otherwise (p = 0.6250). The difference between subjective evaluations of the taste of chewing gums was not significant (p = 0.5879). CONCLUSION:CHX can be successfully incorporated in a chewing gum-based delivery system for use as an adjunct to or even short-term replacement for mechanical plaque control. The observation period needs to be extended if this product is anticipated for longer-term use.