Is Xylitol Toothpaste Effective in Preventing Tooth Decay?

Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With Moderate-to-high Caries Risk? - a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Other: Xylitol toothpaste; Other: Fluoride toothpaste

• Study Type: Interventional
• Enrollment (Actual): 579
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Paediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Infants aged 12-15 months old with high caries risk

Exclusion Criteria:

Infants who has systematical disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Fluoride toothpaste; At-home preventive measures + fluoride (1000 ppm F) toothpaste
Experimental: Test group	Other: Xylitol toothpaste; At-home preventive measures + xylitol-containing (25%) toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical chatting form	Dental caries: Active caries into dentine will be diagnosed at the cavitation level through careful visual inspection. A ball-ended CPI probe will be used to remove food debris or plaque that may obscure visual inspection whenever it is necessary. The degree and severity of the carious lesions will be recorded using ICDAS caries severity codes (Pitts, 2004). Oral hygiene status (VPI): The presence or absence of visible plaque (VPI) on the buccal and lingual surfaces of all primary teeth will be recorded.	2 years
Questionnaire	Questionnaire At the recruitment and before each dental examination, the parent will be asked to complete a questionnaire that assesses their oral health knowledge (causes and prevention of dental caries and periodontal disease), oral health attitude (importance of oral health, the importance of retaining natural teeth, dental service utilisation, and dental health beliefs), and the oral health behaviours of themselves (oral hygiene practices, use of fluoride products and dental attendance patterns) and their infants (feeding, dietary, oral hygiene and toothbrushing habits).	2 years
MS quantitation	Plaque and saliva samples will be collected from the surfaces of the primary teeth and then processed following the protocol by Paster et al. (2001). 'Species-specific' Taqman (real-time) quantitative polymerase chain reaction (Q-RT-PCR) will be used to provide DNA template for quantitative analysis of S. mutans levels	2 years

Collaborators and Investigators

• Sponsor: Dr. Gillian Lee
• Investigators: Study Chair: Gillian Lee, Doctor, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2018
• Primary Completion (Actual): June 6, 2019
• Study Completion (Anticipated): June 6, 2021

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 17106117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No