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

Primary Purpose

Re-mineralization

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
maltitol
xylitol
gum base
Sponsored by
Roquette Management (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Re-mineralization focused on measuring maltitol, xylitol, quantitative light-induced fluorescence, saliva pH, re-mineralization, dental caries

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China College of Stomatology, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

No Intervention

Arm Label

maltitol

xylitol

gum base

no gum

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence

Secondary Outcome Measures

Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip
Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip
Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter
Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter
Change from baseline in Silness & Loe Plaque index at 3 months
Change from baseline in Silness & Loe Plaque index at 6 months

Full Information

First Posted
June 3, 2015
Last Updated
June 7, 2015
Sponsor
Roquette Management (Shanghai) Co., Ltd.
Collaborators
West China College of Stomatology, Kaunas University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02468388
Brief Title
Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
Official Title
Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roquette Management (Shanghai) Co., Ltd.
Collaborators
West China College of Stomatology, Kaunas University of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Re-mineralization
Keywords
maltitol, xylitol, quantitative light-induced fluorescence, saliva pH, re-mineralization, dental caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
maltitol
Arm Type
Experimental
Arm Title
xylitol
Arm Type
Active Comparator
Arm Title
gum base
Arm Type
Placebo Comparator
Arm Title
no gum
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
maltitol
Intervention 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
Intervention Type
Other
Intervention Name(s)
xylitol
Intervention 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
Intervention Type
Other
Intervention Name(s)
gum base
Intervention Description
gum base: 99% gum base; two pellets for 10 min five times each day
Primary Outcome Measure Information:
Title
Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
Time Frame
baseline and 3 months
Title
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 Measure Information:
Title
Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip
Time Frame
baseline and 3 months
Title
Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip
Time Frame
baseline and 6 months
Title
Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter
Time Frame
baseline and 3 months
Title
Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter
Time Frame
baseline and 6 months
Title
Change from baseline in Silness & Loe Plaque index at 3 months
Time Frame
baseline and 3 months
Title
Change from baseline in Silness & Loe Plaque index at 6 months
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deyu Hu, Ph.D.
Organizational Affiliation
West China College of Stomatology, Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China College of Stomatology, Sichuan University
City
Sichuan
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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

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