Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xylitol toothpaste
Fluoride toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
Infants aged 12-15 months old with high caries risk
Exclusion Criteria:
Infants who has systematical disease
Sites / Locations
- Paediatric Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
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).
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04096599
Brief Title
Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
Official Title
Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With Moderate-to-high Caries Risk? - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Gillian Lee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
579 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Xylitol toothpaste
Intervention Description
At-home preventive measures + xylitol-containing (25%) toothpaste
Intervention Type
Other
Intervention Name(s)
Fluoride toothpaste
Intervention Description
At-home preventive measures + fluoride (1000 ppm F) toothpaste
Primary Outcome Measure Information:
Title
Clinical chatting form
Description
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.
Time Frame
2 years
Title
Questionnaire
Description
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).
Time Frame
2 years
Title
MS quantitation
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants aged 12-15 months old with high caries risk
Exclusion Criteria:
Infants who has systematical disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian Lee, Doctor
Organizational Affiliation
The University of Hong Kong
Official's Role
Study Chair
Facility Information:
Facility Name
Paediatric Dentistry
City
Hong Kong
Country
China
12. IPD Sharing Statement
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Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
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