Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
| Sponsors |
Lead Sponsor: Roquette Management (Shanghai) Co., Ltd. Collaborator:
West China College of Stomatology
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| Source | Roquette Management (Shanghai) Co., Ltd. | ||||||||||||||
| 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. |
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| Overall Status | Completed | ||||||||||||||
| Start Date | October 2011 | ||||||||||||||
| Completion Date | June 2012 | ||||||||||||||
| Primary Completion Date | June 2012 | ||||||||||||||
| Phase | N/A | ||||||||||||||
| Study Type | Interventional | ||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 482 | ||||||||||||||
| Condition | |||||||||||||||
| Intervention |
Intervention Type: Other Intervention Name: maltitol Description: 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 Arm Group Label: maltitol Intervention Type: Other Intervention Name: xylitol Description: 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 Arm Group Label: xylitol Intervention Type: Other Intervention Name: gum base Description: gum base: 99% gum base; two pellets for 10 min five times each day Arm Group Label: gum base |
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| Eligibility |
Criteria:
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. Gender: All Minimum Age: 8 Years Maximum Age: 13 Years Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
China |
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| Verification Date |
June 2015 |
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| Responsible Party |
Type: Sponsor |
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| Keywords | |||||||||||||||
| Has Expanded Access | No | ||||||||||||||
| Condition Browse | |||||||||||||||
| Number Of Arms | 4 | ||||||||||||||
| Arm Group |
Label: maltitol Type: Experimental Label: xylitol Type: Active Comparator Label: gum base Type: Placebo Comparator Label: no gum Type: No Intervention |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Masking: Double (Participant, Investigator) |
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