Newly formulated chlorhexidine gluconate chewing gum that gives both anti-plaque effectiveness and an acceptable taste: a double blind, randomized, placebo-controlled trial.
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.


METHODS



METHODS
Randomized, double blind, placebo-controlled crossover trial, employing two 5-day trial periods without mechanical oral hygiene.


METHODS
18 from 22 volunteer dental students (8 males, 10 females, mean age 22 +/- 2.3 years).


METHODS
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.


METHODS
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).


CONCLUSIONS
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.
Kolahi
Jafar
J
Torabinejad Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Soolari
Ahmad
A
Ghalayani
Parichehr
P
Varshosaz
Jaleh
J
Fazilaty
Mohammad
M
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D002638:Chewing Gum; D002710:Chlorhexidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018592:Cross-Over Studies; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010919:Placebos; D013649:Taste / Q000187:drug effects; D016896:Treatment Outcome
D000891:Anti-Infective Agents, Local; D002638:Chewing Gum; D010919:Placebos; C010882:chlorhexidine gluconate; D002710:Chlorhexidine