NCT04096599

Is Xylitol Toothpaste Effective in Preventing Tooth Decay?

Status unknown NA Last updated 20 September 2019

What this trial tests

NA trial testing Xylitol toothpaste in Dental Caries in 579 participants. Status unknown.

Timeline

18 November 2018

Primary endpoint
6 June 2019

6 June 2021

Quick facts

Lead sponsor	Dr. Gillian Lee
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	579
Start date	18 November 2018
Primary completion	6 June 2019
Estimated completion	6 June 2021
Sites	1 location across China

Drugs / interventions tested

• Xylitol toothpaste
• Fluoride toothpaste — full drug profile →

Conditions studied

• Dental Caries — all drugs for Dental Caries →

Sponsor

Dr. Gillian Lee

Who can join

Eligibility, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.