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

Not Applicable

Completed

• Conditions: Re-mineralization
• Interventions: Other: gum base; Other: xylitol; Other: maltitol

• Registration Number: NCT02468388
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-07
• Last Update Submitted: 2015-06-07
• Study First Posted: 2015-06-10
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gum base	gum base	-
xylitol	xylitol	-
maltitol	maltitol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

West China College of Stomatology, Sichuan University; 🇨🇳 Sichuan, Sichuan, China