Is Xylitol Toothpaste Effective in Preventing Tooth Decay?

NCT ID: NCT04096599

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

579 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-18

Study Completion Date

2021-06-06

Brief Summary

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The study will identify children at high caries risk and then advise/instruct their parents/caregivers in practicing evidence-based risk-based at home preventive measures for their infants with daily use of xylitol or fluoride toothpaste. This study plan to invite the children aged 12-15 months old with high caries risk to do the clinical trial. Every infants will be randomly allocated into two groups. Participants in the test group will be asked to use xylitol (20%) toothpaste to brush their teeth twice every day with the help of caregivers. Participants in the test control group will be asked to use fluoride (1000ppm) toothpaste to brush their teeth twice every day with the help of caregivers. The same oral health instruction and children' diet instruction will be done for every participant's caregivers.

For every dental examination, clinical chatting form for the children will be collected after filling in by examiner. Questionnaire will be collected after filling in by the caregivers. And infants' plaque and saliva will be collected to detect the S. mutans level. We plan to do the dental examination three times for one infant including the first time recruiting, one year follow-up, and two year follow-up.

The establishments of the good oral health-related habits will safeguard and have sustained benefits for the children. The study can provide evidence on the effectiveness of xylitol toothpaste and risk of high fluoride toothpaste among young children. In the long term, the findings of the study might serve as a foundation for establishing an effective oral health care promotion programme throughout Hong Kong and beyond. The framework, if shown to be effective, could help development of the oral health policies and promotion programmes to achieve better oral health among young children eventually.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test group

Group Type EXPERIMENTAL

Xylitol toothpaste

Intervention Type OTHER

At-home preventive measures + xylitol-containing (25%) toothpaste

Control group

Group Type ACTIVE_COMPARATOR

Fluoride toothpaste

Intervention Type OTHER

At-home preventive measures + fluoride (1000 ppm F) toothpaste

Interventions

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Xylitol toothpaste

At-home preventive measures + xylitol-containing (25%) toothpaste

Intervention Type OTHER

Fluoride toothpaste

At-home preventive measures + fluoride (1000 ppm F) toothpaste

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Infants aged 12-15 months old with high caries risk

Exclusion Criteria

Infants who has systematical disease
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Gillian Lee

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gillian Lee

Clinical Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gillian Lee, Doctor

Role: STUDY_CHAIR

The University of Hong Kong

Locations

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Paediatric Dentistry

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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17106117

Identifier Type: -

Identifier Source: org_study_id

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