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

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.

Study Overview

• Status: Completed
• Conditions: Re-mineralization
• Intervention / Treatment: Other: maltitol; Other: xylitol; Other: gum base

• Study Type: Interventional
• Enrollment (Actual): 482
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Sichuan, Sichuan, China, 610041
      • West China College of Stomatology, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Roquette Management (Shanghai) Co., Ltd.
• Collaborators: Kaunas University of Medicine; West China College of Stomatology
• Investigators: Principal Investigator: Deyu Hu, Ph.D., West China College of Stomatology, Sichuan University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 7, 2015
• First Posted (ESTIMATE): June 10, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 7, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: xylitol; dental caries; maltitol; quantitative light-induced fluorescence; saliva pH; re-mineralization
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: CPS 10-341