Dental CariesNCT01310283
Caries Management by Risk Assessment in Children
A study testing xylitol mints and fluoride varnish in people with Dental Caries, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- xylitol mints and fluoride varnish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to May 2012
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be:
- Patients of record at the Tenderloin community and UCSF pediatric dental clinics
- 5-9 years old
- 3. Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian 4. Be unlikely to move from the area during the study period 5. Be willing to participate regardless of group assignment and comply with all study procedures
Who cannot join
- Persons with:
- Prolonged antibiotic use in the past three months.
- Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School
San Francisco, California, 94143
The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School
San Francisco, California, 94143
About this study
The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.
- Conditions
- Dental Caries
- Being tested
- xylitol mints and fluoride varnish
- Keywords
- dental caries, children, mutans streptococci, lactobacilli, cariogenic bacteria
- 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 mints and fluoride varnishOther
Subjects in the intervention group will receive additional diet, oral hygiene handouts, more frequent professional fluoride application, and xylitol mints based on their caries risk levels.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Conventional pediatric dental care. Receives: Other: xylitol mints and fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
new decayed surfaces
Measured: 1 year
Secondary outcomes (1)
cariogenic bacteria levels
Measured: 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
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.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Zhan, University of California, San Francisco
- Investigators
- Ling Zhan, DDS, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310283
- Sponsor's protocol ID
- A106017
- Status last verified
- Nov 2012
- First submitted
- 4 Mar 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Management by Risk Assessment in Children
- ClinicalTrials.gov ID
- NCT01310283
- Acronym / sponsor ID
- A106017
- Conditions
- Dental Caries
- Keywords
- dental caries, children, mutans streptococci, lactobacilli, cariogenic bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Mar 2011 (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.
The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | Other: xylitol mints and fluoride varnishConventional pediatric dental care. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be:
- Patients of record at the Tenderloin community and UCSF pediatric dental clinics
- 5-9 years old
- 3. Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian 4. Be unlikely to move from the area during the study period 5. Be willing to participate regardless of group assignment and comply with all study procedures
Key exclusion criteria (3 listed)
- Prolonged antibiotic use in the past three months.
- Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics
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 mints and fluoride varnishSubjects in the intervention group will receive additional diet, oral hygiene handouts, more frequent professional fluoride application, and xylitol mints based on their caries risk levels. | Other | control group |
Primary outcome
new decayed surfaces
Time frame: 1 year
1 secondary outcome
cariogenic bacteria levels
Time frame: 6 month and 1 year
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 14 Nov 2012.
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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.
Ling Zhan, DDS, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xylitol mints and fluoride varnish in people with Dental Caries, run by University of California, San Francisco at 2 sites in United States.
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 4 inclusion and 3 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 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
new decayed surfaces (time frame: 1 year). 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 14 Nov 2012.