Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
NCT ID: NCT02468388
Last Updated: 2015-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
482 participants
INTERVENTIONAL
2011-10-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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maltitol
maltitol
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
xylitol
xylitol
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
gum base
gum base
gum base: 99% gum base; two pellets for 10 min five times each day
no gum
No interventions assigned to this group
Interventions
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maltitol
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
xylitol
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
gum base
gum base: 99% gum base; two pellets for 10 min five times each day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
8 Years
13 Years
ALL
No
Sponsors
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West China College of Stomatology
OTHER
Kaunas University of Medicine
OTHER
Roquette Management (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Deyu Hu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
West China College of Stomatology, Sichuan University
Locations
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West China College of Stomatology, Sichuan University
Sichuan, Sichuan, China
Countries
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Other Identifiers
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CPS 10-341
Identifier Type: -
Identifier Source: org_study_id
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