Clinical Trial: Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence

Brief Summary: The purpose of this study is to evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group.

Detailed Summary:
Sponsor: Roquette Management (Shanghai) Co., Ltd.

Current Primary Outcome:

  • Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence [ Time Frame: baseline and 3 months ]
  • Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence [ Time Frame: baseline and 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip [ Time Frame: baseline and 3 months ]
  • Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip [ Time Frame: baseline and 6 months ]
  • Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter [ Time Frame: baseline and 3 months ]
  • Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter [ Time Frame: baseline and 6 months ]
  • Change from baseline in Silness & Loe Plaque index at 3 months [ Time Frame: baseline and 3 months ]
  • Change from baseline in Silness & Loe Plaque index at 6 months [ Time Frame: baseline and 6 months ]


Original Secondary Outcome: Same as current

Information By: Roquette Management (Shanghai) Co., Ltd.

Dates:
Date Received: June 3, 2015
Date Started: October 2011
Date Completion:
Last Updated: June 7, 2015
Last Verified: June 2015