Re-mineralization Clinical Trial
Official title:
Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
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.
| Status | Completed |
| Enrollment | 482 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 8 Years to 13 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | West China College of Stomatology, Sichuan University | Sichuan | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Roquette Management (Shanghai) Co., Ltd. | Kaunas University of Medicine, West China College of Stomatology |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence | baseline and 3 months | No | |
| Primary | Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence | baseline and 6 months | No | |
| Secondary | Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip | baseline and 3 months | No | |
| Secondary | Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip | baseline and 6 months | No | |
| Secondary | Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter | baseline and 3 months | No | |
| Secondary | Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter | baseline and 6 months | No | |
| Secondary | Change from baseline in Silness & Loe Plaque index at 3 months | baseline and 3 months | No | |
| Secondary | Change from baseline in Silness & Loe Plaque index at 6 months | baseline and 6 months | No |