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

Study Overview
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Brief Summary
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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.

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

Conditions
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Re-mineralization

Intervention / Treatment
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* Other: maltitol
* Other: xylitol
* Other: gum base


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maltitol<br> | Other: maltitol<br>* 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<br>|
| Active Comparator: xylitol<br> | Other: xylitol<br>* 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<br>|
| Placebo Comparator: gum base<br> | Other: gum base<br>* gum base: 99% gum base; two pellets for 10 min five times each day<br>|
| No Intervention: no gum<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maltitol, xylitol, quantitative light-induced fluorescence, saliva pH, re-mineralization, dental caries