Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence

Roquette Management (Shanghai) Co., Ltd.1 site in 1 country482 target enrollmentOctober 2011

ConditionsRe-mineralization

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Re-mineralization
Sponsor: Roquette Management (Shanghai) Co., Ltd.
Enrollment: 482
Locations: 1
Primary Endpoint: Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

June 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Roquette Management (Shanghai) Co., Ltd.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: baseline and 3 months

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 Outcomes

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)