NCT02468388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
482

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

June 3, 2015

Last Update Submit

June 7, 2015

Conditions

Re-mineralization

Keywords

maltitolxylitolquantitative light-induced fluorescencesaliva pHre-mineralizationdental caries

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

maltitol

EXPERIMENTAL
Other: maltitol

xylitol

ACTIVE COMPARATOR
Other: xylitol

gum base

PLACEBO COMPARATOR
Other: gum base

no gum

NO INTERVENTION

Interventions

maltitolOTHER

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

maltitol
xylitolOTHER

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

xylitol
gum baseOTHER

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

gum base

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China College of Stomatology, Sichuan University

Sichuan, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Dental Caries

Interventions

maltitolXylitol

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Deyu Hu, Ph.D.

    West China College of Stomatology, Sichuan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 10, 2015

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

CN(1)