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