Dental CariesNCT04096599
Is Xylitol Toothpaste Effective in Preventing Tooth Decay?
A study testing Xylitol toothpaste and Fluoride toothpaste in people with Dental Caries, run by Dr. Gillian Lee at 1 site in China.
Trial summary
The study will identify children at high caries risk and provide their parents/caregivers with evidence-based, risk-based at-home preventive measures for their infants, including daily use of xylitol or fluoride toothpaste. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Xylitol toothpaste and Fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2018to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 12-16 months old
- High caries risk
Who cannot join
- Having systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With High Caries Risk? - a Randomized Controlled Trial
The study will identify children at high caries risk and provide their parents/caregivers with evidence-based, risk-based at-home preventive measures for their infants, including daily use of xylitol or fluoride toothpaste. Infants aged 12-16 months with high caries risk will be invited to participate in the clinical trial. Each infant will be randomly allocated to one of two groups. In the test group, parents will be asked to use xylitol (25%) toothpaste to brush their toddler's teeth twice daily. Parents in the control group will be asked to use fluoride (1000ppm) toothpaste to brush their toddler's teeth twice daily. Identical oral health instruction and children's diet instruction will be given to every participant's caregivers.
For each dental examination, an examiner will assess dental caries and oral hygiene status of infants using a standard charting form. Caregivers will complete a questionnaire. The infants' plaque and saliva will be collected to quantify Streptococcus mutans. Data will be collected at baseline, one-year and two-year follow-ups.
The establishment of good oral health-related habits will safeguard and provide sustained benefits for the children. This study aims to provide evidence on the effectiveness of xylitol toothpaste and the risk of high fluoride toothpaste among young children. In the long term, findings from this study could provide the foundation for an effective oral health care promotion programme throughout Hong Kong and beyond. If shown to be effective, the framework could inform the development of oral health policies and promotion programmes to improve the oral health of young children.
- Conditions
- Dental Caries
- Being tested
- Xylitol toothpaste, Fluoride toothpaste
- Keywords
- Oral health, Early childhood caries, Toothbrushing, Dentifrices, Randomised clinical trial, Xylitol
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol toothpasteOther
At-home preventive measures + xylitol-containing (25%) toothpaste
Fluoride toothpasteOther
At-home preventive measures + fluoride (1000 ppm F) toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Xylitol toothpaste |
| Control group | Active comparator | Not described Receives: Other: Fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries (cavitated lesion)
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 Modified International Caries Detection and Assessment System (ICDAS II) caries severity codes (0 to 6).
The proportion of toddlers with a cavitated lesion (CL, ICDAS II codes 3-6) will be calculated.
Measured: Baseline, 1-year and 2-year follow-up
Secondary outcomes (4)
Dental caries (white spot lesion)
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 Modified International Caries Detection and Assessment System (ICDAS II) caries severity codes (0 to 6).
The proportion of toddlers with a white spot lesion (WSL, ICDAS II codes 1 and 2) will be calculated.
Measured: Baseline, 1-year and 2-year follow-up
Dental caries experience (dmft)
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 dental caries experience of the toddlers will be recorded as the number of decayed, missing, and filled primary teeth (dmft index).
Measured: Baseline, 1-year and 2-year follow-up
Oral hygiene status (VPI)
Dental plaque deposits on the buccal, palatal/lingual, mesial and distal surfaces of all erupted primary teeth were examined. Plaque index (PI) (score 0, 1, 2, 3) will be used to record the amount of dental plaque accumulation (Silness \& Löe, 1964).
The proportion of toddlers with visible plaque (VP) will be calculated based on codes 2 and 3.
Measured: Baseline, 1-year and 2-year follow-up
Streptococcus mutans (MS)
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.
Measured: Baseline, 1-year and 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start8 Nov 2018
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Gillian Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Gillian Lee, The University of Hong Kong
- Investigators
- Gillian Lee, Doctor, Study chair, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096599
- Sponsor's protocol ID
- 17106117
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With High Caries Risk? - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04096599
- Acronym / sponsor ID
- 17106117
- Conditions
- Dental Caries
- Keywords
- Oral health, Early childhood caries, Toothbrushing, Dentifrices, Randomised clinical trial, Xylitol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Dr. Gillian LeeUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will identify children at high caries risk and provide their parents/caregivers with evidence-based, risk-based at-home preventive measures for their infants, including daily use of xylitol or fluoride toothpaste. Infants aged 12-16 months with high caries risk will be invited to participate in the clinical trial. Each infant will be randomly allocated to one of two groups. In the test group, parents will be asked to use xylitol (25%) toothpaste to brush their toddler's teeth twice daily. Parents in the control group will be asked to use fluoride (1000ppm) toothpaste to brush their toddler's teeth twice daily. Identical oral health instruction and children's diet instruction will be given to every participant's caregivers.
For each dental examination, an examiner will assess dental caries and oral hygiene status of infants using a standard charting form. Caregivers will complete a questionnaire. The infants' plaque and saliva will be collected to quantify Streptococcus mutans. Data will be collected at baseline, one-year and two-year follow-ups.
The establishment of good oral health-related habits will safeguard and provide sustained benefits for the children. This study aims to provide evidence on the effectiveness of xylitol toothpaste and the risk of high fluoride toothpaste among young children. In the long term, findings from this study could provide the foundation for an effective oral health care promotion programme throughout Hong Kong and beyond. If shown to be effective, the framework could inform the development of oral health policies and promotion programmes to improve the oral health of young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Xylitol toothpaste |
| Control group | Active comparator | Other: Fluoride toothpaste |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 12-16 months old
- High caries risk
Key exclusion criteria (1 listed)
- Having systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol toothpasteAt-home preventive measures + xylitol-containing (25%) toothpaste | Other | Test group |
| Fluoride toothpasteAt-home preventive measures + fluoride (1000 ppm F) toothpaste | Other | Control group |
Primary outcome
Dental caries (cavitated lesion)
Time frame: Baseline, 1-year and 2-year follow-up
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 Modified International Caries Detection and Assessment System (ICDAS II) caries severity codes (0 to 6). The proportion of toddlers with a cavitated lesion (CL, ICDAS II codes 3-6) will be calculated.
4 secondary outcomes
Dental caries (white spot lesion)
Time frame: Baseline, 1-year and 2-year follow-up
Dental caries experience (dmft)
Time frame: Baseline, 1-year and 2-year follow-up
Oral hygiene status (VPI)
Time frame: Baseline, 1-year and 2-year follow-up
Streptococcus mutans (MS)
Time frame: Baseline, 1-year and 2-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gillian Lee, Doctor study chair
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol toothpaste and Fluoride toothpaste in people with Dental Caries, run by Dr. Gillian Lee at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental caries (cavitated lesion) (time frame: Baseline, 1-year and 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.