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Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468388
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Collaborators:
West China College of Stomatology
Kaunas University of Medicine
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Re-mineralization Other: maltitol Other: xylitol Other: gum base Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
Study Start Date : October 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
Drug Information available for: Xylitol

Arm Intervention/treatment
Experimental: maltitol Other: 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

Active Comparator: xylitol Other: 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

Placebo Comparator: gum base Other: gum base
gum base: 99% gum base; two pellets for 10 min five times each day

No Intervention: no gum



Primary Outcome Measures :
  1. Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence [ Time Frame: baseline and 3 months ]
  2. Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence [ Time Frame: baseline and 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip [ Time Frame: baseline and 3 months ]
  2. Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip [ Time Frame: baseline and 6 months ]
  3. Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter [ Time Frame: baseline and 3 months ]
  4. Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter [ Time Frame: baseline and 6 months ]
  5. Change from baseline in Silness & Loe Plaque index at 3 months [ Time Frame: baseline and 3 months ]
  6. Change from baseline in Silness & Loe Plaque index at 6 months [ Time Frame: baseline and 6 months ]


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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468388


Locations
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China, Sichuan
West China College of Stomatology, Sichuan University
Sichuan, Sichuan, China, 610041
Sponsors and Collaborators
Roquette Management (Shanghai) Co., Ltd.
West China College of Stomatology
Kaunas University of Medicine
Investigators
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Principal Investigator: Deyu Hu, Ph.D. West China College of Stomatology, Sichuan University
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Responsible Party: Roquette Management (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02468388    
Other Study ID Numbers: CPS 10-341
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by Roquette Management (Shanghai) Co., Ltd.:
maltitol
xylitol
quantitative light-induced fluorescence
saliva pH
re-mineralization
dental caries
Additional relevant MeSH terms:
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Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases