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

Roquette

Status: Completed

Conditions: Re-mineralization

Treatments: Other: gum base; Other: maltitol; Other: xylitol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02468388

CPS 10-341

Details and patient eligibility

About

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.

Enrollment: 482 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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482 participants in 4 patient groups, including a placebo group

maltitol

Experimental group

Treatment:

Other: maltitol

xylitol

Active Comparator group

Treatment:

Other: xylitol

gum base

Placebo Comparator group

Treatment:

Other: gum base

no gum

No Intervention group