Skip to main content
OpenTrials
Completed

NCT Number: NCT02468388

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China College of Stomatology, Sichuan University

Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

maltitol

Other

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

xylitol

Other

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

gum base

Other

gum base: 99% gum base; two pellets for 10 min five times each day

Primary outcomes

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

    Time frame: baseline and 3 months

  2. 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

  1. Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip

    Time frame: baseline and 3 months

  2. Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip

    Time frame: baseline and 6 months

  3. Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter

    Time frame: baseline and 3 months

  4. Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter

    Time frame: baseline and 6 months

  5. Change from baseline in Silness & Loe Plaque index at 3 months

    Time frame: baseline and 3 months

  6. Change from baseline in Silness & Loe Plaque index at 6 months

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

Roquette Management (Shanghai) Co., Ltd.

Industry

Collaborators

  • Kaunas University of Medicine
  • West China College of Stomatology

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2015
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.