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

Sponsors

Lead Sponsor: Roquette Management (Shanghai) Co., Ltd.

Collaborator: West China College of Stomatology
Kaunas University of Medicine

Source 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.

Overall Status Completed
Start Date October 2011
Completion Date June 2012
Primary Completion Date June 2012
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: maltitol

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: xylitol

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: gum base

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
Location Countries

China

Verification Date

June 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: maltitol

Type: Experimental

Label: xylitol

Type: Active Comparator

Label: gum base

Type: Placebo Comparator

Label: no gum

Type: No Intervention

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov