Dental CariesPhase 3NCT02341352
Three Measures for the Prevention of Carious Lesions in Preschool Children
A Phase 3 study testing fluoride varnish, Immunoglobulin Yolk and Probiotics in people with Dental Caries, run by Zhejiang University at 1 site in China.
Trial summary
Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children Read more about this study
- Who is it for?
- Ages 24 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- fluoride varnish, Immunoglobulin Yolk and Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Jun 2015
- Phase
- Phase 3
- 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 24 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preschool children in good general health
- At least 18 deciduous teeth
Who cannot join
- With major systemic disease or on long-term medication
- Not cooperative and refuse dental treatment
- With a history of extra fluoride supplement
- Take antibiotics for nearly 8 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
Official title: Study on Children's Dental Caries Prevention and Mechanism
Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children
Read the detailed description
Different caries prevention trials including fluoride vanish, IgY-passive immunotherapy and probiotics lasting 24 months were conducted with a total of 500 children aged 24 to 54 months of age in Lin'an, Zhejiang, China. The trials were cluster- domized .After obtaining parent´s informed consent, preschool children were clinical examinated according to ICDAS-Ⅱ and microbiological tested of saliva at baseline, 1m, 6m, 12m, 18m and 24m. To find the differences of caries incidence and oral microecology change in four groups, dmfs will be assessed and saliva will be analysed in experiment.
- Conditions
- Dental Caries
- Being tested
- fluoride varnish, Immunoglobulin Yolk, Probiotics
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoride varnishDrug
Also called Duraphat(Colgate-palmolive company)
Sodium fluoride 50mg/ml
Immunoglobulin YolkBiological
Also called Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech)
anti-Streptococcus mutans IgY
ProbioticsDietary supplement
Also called Probiotics milk power(Minsheng Pharmaceutical)
2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Only behavioral education for Caregiver |
| fluoride varnish | Experimental | fluoride varnish every 6 months Receives: Drug: fluoride varnish |
| ImmunoglobulinY | Experimental | anti-S.mutans Immunoglobulin yolk for everyday use Receives: Biological: Immunoglobulin Yolk |
| Probiotics | Experimental | Probiotics use for 1 months Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of new cavitated or incipient carious lesion
To determine whether preschool children that only with caregiver behavior education have more new caries lesion than those taken some caries preventive measures by differences in dmfs（decay，missing，filling teeth surfaces） index after 24 months dental exams.
Measured: 24 months after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Occupational Disease Prevention Hospital
- Responsible party
- Principal investigator, Xi Chen, Zhejiang University
- Investigators
- Hui Chen, Principal investigator, Department of Conservative Dentistry and Periodontics, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341352
- Sponsor's protocol ID
- 2013-8
- Other IDs
- 81371142, 20120633B14
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2015
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang J, Su L, Wang Y, Deng S. Improved High-Throughput Sequencing of the Human Oral Microbiome: From Illumina to PacBio. Can J Infect Dis Med Microbiol. 2020 Dec 11;2020:6678872. doi: 10.1155/2020/6678872. eCollection 2020.
PubMed 33381248Wang Y, Wang S, Wu C, Chen X, Duan Z, Xu Q, Jiang W, Xu L, Wang T, Su L, Wang Y, Chen Y, Zhang J, Huang Y, Tong S, Zhou C, Deng S, Qin N. Oral Microbiome Alterations Associated with Early Childhood Caries Highlight the Importance of Carbohydrate Metabolic Activities. mSystems. 2019 Nov 5;4(6):e00450-19. doi: 10.1128/mSystems.00450-19.
PubMed 31690590
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Children's Dental Caries Prevention and Mechanism
- ClinicalTrials.gov ID
- NCT02341352
- Acronym / sponsor ID
- 2013-8
- Conditions
- Dental Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Occupational Disease Prevention Hospital
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- 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.
Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children
Detailed description
Different caries prevention trials including fluoride vanish, IgY-passive immunotherapy and probiotics lasting 24 months were conducted with a total of 500 children aged 24 to 54 months of age in Lin'an, Zhejiang, China. The trials were cluster- domized .After obtaining parent´s informed consent, preschool children were clinical examinated according to ICDAS-Ⅱ and microbiological tested of saliva at baseline, 1m, 6m, 12m, 18m and 24m. To find the differences of caries incidence and oral microecology change in four groups, dmfs will be assessed and saliva will be analysed in experiment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Only behavioral education for Caregiver |
| fluoride varnish | Experimental | Drug: fluoride varnishfluoride varnish every 6 months |
| ImmunoglobulinY | Experimental | Biological: Immunoglobulin Yolkanti-S.mutans Immunoglobulin yolk for everyday use |
| Probiotics | Experimental | Dietary Supplement: ProbioticsProbiotics use for 1 months |
Who may qualify
- Ages
- 24 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preschool children in good general health
- At least 18 deciduous teeth
Key exclusion criteria (4 listed)
- With major systemic disease or on long-term medication
- Not cooperative and refuse dental treatment
- With a history of extra fluoride supplement
- Take antibiotics for nearly 8 weeks
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 |
|---|---|---|
| fluoride varnishAlso: Duraphat(Colgate-palmolive company)Sodium fluoride 50mg/ml | Drug | fluoride varnish |
| Immunoglobulin YolkAlso: Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech)anti-Streptococcus mutans IgY | Biological | ImmunoglobulinY |
| ProbioticsAlso: Probiotics milk power(Minsheng Pharmaceutical)2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder | Dietary supplement | Probiotics |
Primary outcome
The number of new cavitated or incipient carious lesion
Time frame: 24 months after first visit
To determine whether preschool children that only with caregiver behavior education have more new caries lesion than those taken some caries preventive measures by differences in dmfs（decay，missing，filling teeth surfaces） index after 24 months dental exams.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Derived from this study: PubMed 33381248Zhang J, Su L, Wang Y, Deng S. Improved High-Throughput Sequencing of the Human Oral Microbiome: From Illumina to PacBio. Can J Infect Dis Med Microbiol. 2020 Dec 11;2020:6678872. doi: 10.1155/2020/6678872. eCollection 2020.
- Derived from this study: PubMed 31690590Wang Y, Wang S, Wu C, Chen X, Duan Z, Xu Q, Jiang W, Xu L, Wang T, Su L, Wang Y, Chen Y, Zhang J, Huang Y, Tong S, Zhou C, Deng S, Qin N. Oral Microbiome Alterations Associated with Early Childhood Caries Highlight the Importance of Carbohydrate Metabolic Activities. mSystems. 2019 Nov 5;4(6):e00450-19. doi: 10.1128/mSystems.00450-19.
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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.
Hui Chen principal investigator
Department of Conservative Dentistry and Periodontics, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluoride varnish, Immunoglobulin Yolk and Probiotics in people with Dental Caries, run by Zhejiang University 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 4 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: status not confirmed, as of the sponsor's last update on 19 Jan 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The number of new cavitated or incipient carious lesion (time frame: 24 months after first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341352, which also lists 2 linked publications.
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 19 Jan 2015.