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Is Xylitol Toothpaste Effective in Preventing Tooth Decay?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096599
Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Gillian Lee, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Dental Caries Other: Xylitol toothpaste Other: Fluoride toothpaste Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With Moderate-to-high Caries Risk? - a Randomized Controlled Trial
Actual Study Start Date : November 18, 2018
Actual Primary Completion Date : June 6, 2019
Estimated Study Completion Date : June 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Test group Other: Xylitol toothpaste
At-home preventive measures + xylitol-containing (25%) toothpaste

Active Comparator: Control group Other: Fluoride toothpaste
At-home preventive measures + fluoride (1000 ppm F) toothpaste




Primary Outcome Measures :
  1. Clinical chatting form [ Time Frame: 2 years ]

    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. Questionnaire [ Time Frame: 2 years ]
    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).

  3. MS quantitation [ Time Frame: 2 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Infants aged 12-15 months old with high caries risk

Exclusion Criteria:

Infants who has systematical disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096599


Locations
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China
Paediatric Dentistry
Hong Kong, China
Sponsors and Collaborators
Dr. Gillian Lee
Investigators
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Study Chair: Gillian Lee, Doctor The University of Hong Kong
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Responsible Party: Dr. Gillian Lee, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04096599    
Other Study ID Numbers: 17106117
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs