Re-mineralization
Conditions
Keywords
maltitol, xylitol, quantitative light-induced fluorescence, saliva pH, re-mineralization, dental caries
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.
Interventions
OTHERmaltitol
maltitol chewing gum: 66% SweetPearlTM Maltitol +30.91% gum base+1.93% Lycasin R 85/55+0.39% glycerin; two pellets for 10 min five times each day
OTHERxylitol
xylitol chewing gum: 67.73% xylitol +30.02% gum base+1.13% Lycasin R 85/55+0.38% glycerin; two pellets for 10 min five times each day
OTHERgum base
gum base: 99% gum base; two pellets for 10 min five times each day
Sponsors
West China College of Stomatology
Kaunas University of Medicine
Roquette Management (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Consent Informed Consent Form signed by parent or legal guardian permitting participation of their children. * Be cooperative and able to be examined in the whole study duration. * Aged from 8 to 13 years. * General Health: Good general health (in the opinion of the investigator) without clinically significant and relevant abnormalities of medical history such as diabetic, etc. * Oral Health: Display 6 permanent front teeth and two maxillary buccal surfaces with visual evidence of active initial enamel carious lesions (de-mineralized but not cavitated); No any form of intraoral prostheses or appliances, clinical signs of severe gingivitis or periodontitis, temporomandibular joint disorders, and malocclusions or chronic onychophagia * Oral Hygiene: have good oral health habits, brushing teeth at least once per day * No medical or pharmacotherapy history that might affect the outcomes of the study, e.g. use of mouthwash, gels, or chewing gum containing antimicrobial agents during the previous 3 months
Exclusion criteria
* Disease: Presence of chronic debilitating disease, or any condition or other chronic disease which the investigators think not suitable for the study. * Allergy/Intolerance: Be allergic to both maltitol and xylitol, oral care products, personal care consumer products, or their ingredients. * Current Product Use: usual chewing-gum (of any kind) consumer or sugars-free candies consumer * Clinical Study/Experiment: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence | baseline and 3 months |
| Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence | baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter | baseline and 3 months |
| Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter | baseline and 6 months |
| Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip | baseline and 3 months |
| Change from baseline in Silness & Loe Plaque index at 6 months | baseline and 6 months |
| Change from baseline in Silness & Loe Plaque index at 3 months | baseline and 3 months |
| Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip | baseline and 6 months |
Countries
China
Outcome results
None listed