Down SyndromePhase 2NCT01975545
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
A Phase 2 study testing Fluor varnish and Fluor varnish with nanoparticles in people with Down Syndrome, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Fluor varnish and Fluor varnish with nanoparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2012to May 2014
- Phase
- Phase 2
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with trisomy 21 diagnosed through caryotype
- Age 1 to 6 years old
- Any sex
- White spot present in both upper anterior teeth
- Parental agreement to participate in the study
Who cannot join
- Hypersensibility to any of the substances used
- Non cooperating patients
- Caries in enamel or dentine in the upper anterior teeth
- Leukemia or diabetes
- Dental fluorosis present
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, 78210
About this study
Official title: Efficacy of the Addition of Silver Nanoparticles to a Fluor Varnish in the Remineralization of Temporary Teeth in Patients With Trisomy 21. Randomized Clinical Trial.
Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question.
- Conditions
- Down Syndrome
- Being tested
- Fluor varnish, Fluor varnish with nanoparticles
- Keywords
- Down syndrome, Caries, Dental varnish
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluor varnishDrug
Also called Fluor dental varnish
Dental varnish will be applied to one anterior superior teeth in a random side.
Fluor varnish with nanoparticlesDrug
Also called Fluor dental varnish with silver nanoparticles.
Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.
| Study group | Role | What they receive |
|---|---|---|
| Fluor varnish | Active comparator | Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) Receives: Drug: Fluor varnish |
| Fluor varnish with nanoparticles | Experimental | Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles. Receives: Drug: Fluor varnish with nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization
Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Butrón Téllez Girón, Universidad Autonoma de San Luis Potosí
- Investigators
- Mauricio Pierdant-Pérez, Md, MSc, Study director, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975545
- Sponsor's protocol ID
- MCIC-001
- Status last verified
- Mar 2014
- First submitted
- 3 Sep 2013
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Addition of Silver Nanoparticles to a Fluor Varnish in the Remineralization of Temporary Teeth in Patients With Trisomy 21. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01975545
- Acronym / sponsor ID
- MCIC-001
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Caries, Dental varnish
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 4 Nov 2013 (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.
Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluor varnish | Active comparator | Drug: Fluor varnishFluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) |
| Fluor varnish with nanoparticles | Experimental | Drug: Fluor varnish with nanoparticlesFluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients with trisomy 21 diagnosed through caryotype
- Age 1 to 6 years old
- Any sex
- White spot present in both upper anterior teeth
- Parental agreement to participate in the study
Key exclusion criteria (5 listed)
- Hypersensibility to any of the substances used
- Non cooperating patients
- Caries in enamel or dentine in the upper anterior teeth
- Leukemia or diabetes
- Dental fluorosis present
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 |
|---|---|---|
| Fluor varnishAlso: Fluor dental varnishDental varnish will be applied to one anterior superior teeth in a random side. | Drug | Fluor varnish |
| Fluor varnish with nanoparticlesAlso: Fluor dental varnish with silver nanoparticles.Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side. | Drug | Fluor varnish with nanoparticles |
Primary outcome
Remineralization
Time frame: 3 months
Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
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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.
Mauricio Pierdant-Pérez, Md, MSc study director
Universidad Autonoma de San Luis Potosí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluor varnish and Fluor varnish with nanoparticles in people with Down Syndrome, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 5 inclusion and 5 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 7 Mar 2014. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Remineralization (time frame: 3 months). 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 7 Mar 2014.