Clinical trial NCT02468388: Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
Official title: Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Re-mineralization
Keywords: maltitol
xylitol
quantitative light-induced fluorescence
saliva pH
re-mineralization
dental caries
Lead sponsor: Roquette Management (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: West China College of Stomatology
name: Kaunas University of Medicine
First posted: 2015-06-10
Enrollment: 482
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
timeFrame: baseline and 3 months
measure: Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip
timeFrame: baseline and 3 months
measure: Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip
timeFrame: baseline and 6 months
measure: Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter
timeFrame: baseline and 3 months
measure: Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter
timeFrame: baseline and 6 months
measure: Change from baseline in Silness & Loe Plaque index at 3 months
timeFrame: baseline and 3 months
measure: Change from baseline in Silness & Loe Plaque index at 6 months
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Sichuan
country: China
facility: West China College of Stomatology, Sichuan University
state: Sichuan
Study officials:
affiliation: West China College of Stomatology, Sichuan University
name: Deyu Hu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: