Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
Sponsors
Lead Sponsor
Collaborators
Source
Roquette Management (Shanghai) Co., Ltd.
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2011-10-01
Completion Date
2012-06-01
Primary Completion Date
2012-06-01
Phase
N/A
Study Type
Interventional
Primary Outcome
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 Outcome
Measure |
Time Frame |
|
Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip |
baseline and 3 months |
|
Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip |
baseline and 6 months |
|
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 Silness & Loe Plaque index at 3 months |
baseline and 3 months |
|
Change from baseline in Silness & Loe Plaque index at 6 months |
baseline and 6 months |
Enrollment
482
Condition
Intervention
Intervention Type
Other
Intervention Name
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
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
Description
gum base: 99% gum base; two pellets for 10 min five times each day
Arm Group Label
gum base
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
Overall Official
Last Name |
Role |
Affiliation |
|
Deyu Hu, Ph.D. |
Principal Investigator |
West China College of Stomatology, Sichuan University |
Location
Facility |
|
West China College of Stomatology, Sichuan University Sichuan Sichuan 610041 China |
Location Countries
Country
China
Verification Date
2015-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
4
Arm Group
Arm Group Label
maltitol
Arm Group Type
Experimental
Arm Group Label
xylitol
Arm Group Type
Active Comparator
Arm Group Label
gum base
Arm Group Type
Placebo Comparator
Arm Group Label
no gum
Arm Group Type
No Intervention
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)
Study First Submitted
June 3, 2015
Study First Submitted Qc
June 7, 2015
Study First Posted
June 10, 2015
Last Update Submitted
June 7, 2015
Last Update Submitted Qc
June 7, 2015
Last Update Posted
June 10, 2015
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.