White Spot LesionsNCT01500187
Fluoride Varnish for Treatment of White Spot Lesions
A study testing Vanish Varnish and Pediagel in people with White Spot Lesions, run by Solventum US LLC at 1 site in United States.
Trial summary
Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Vanish Varnish and Pediagel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 31 Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no systemic disease
- has completed fixed orthodontic treatment, brackets debonded
- has at least two teeth with whitre spot lesions
- has received conventional periodontal therapy after orthodontic tretament
Who cannot join
- presence of enamel hypoplasia or dental fluorosis
- presence of tetracycline pigmentation
- periodontal pocketing of 3mm or greater
- taking antibiotics
- presence of carious cavities
- allergy to fluoride gel / varnish being used in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.
Read the detailed description
To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.
- Conditions
- White Spot Lesions
- Being tested
- Vanish Varnish, Pediagel
- Keywords
- white spot lesions, fixed orthodontic brackets, fluoride varnish, fluoride gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanish VarnishDevice
5% sodium fluoride varnish with tricalcium phosphate
PediagelDevice
1.23% Acidulated Phosphate Fluoride Gel
| Study group | Role | What they receive |
|---|---|---|
| Pediagel | Active comparator | 1.23% Acidulated Phosphate Fluoride Gel Receives: Device: Pediagel |
| 3M Vanish Varnish | Experimental | 5% sodium fluoride varnish Receives: Device: Vanish Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.
Measured: Baseline, Three and Six Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completion31 Mar 2014
- Study completion31 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for White Spot LesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tennessee, 3M
- Responsible party
- Sponsor
- Investigators
- Franklin Garcia-Godoy, DDS, MS, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500187
- Sponsor's protocol ID
- CR-11-011
- Other IDs
- ORTHO2011-01
- Status last verified
- Sep 2024
- First submitted
- 22 Dec 2011
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
- ClinicalTrials.gov ID
- NCT01500187
- Acronym / sponsor ID
- CR-11-011
- Conditions
- White Spot Lesions
- Keywords
- white spot lesions, fixed orthodontic brackets, fluoride varnish, fluoride gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Tennessee, 3M
- Study start
- Feb 2012
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 31 Mar 2014 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.
Detailed description
To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediagel | Active comparator | Device: Pediagel1.23% Acidulated Phosphate Fluoride Gel |
| 3M Vanish Varnish | Experimental | Device: Vanish Varnish5% sodium fluoride varnish |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- no systemic disease
- has completed fixed orthodontic treatment, brackets debonded
- has at least two teeth with whitre spot lesions
- has received conventional periodontal therapy after orthodontic tretament
Key exclusion criteria (6 listed)
- presence of enamel hypoplasia or dental fluorosis
- presence of tetracycline pigmentation
- periodontal pocketing of 3mm or greater
- taking antibiotics
- presence of carious cavities
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 |
|---|---|---|
| Vanish Varnish5% sodium fluoride varnish with tricalcium phosphate | Device | 3M Vanish Varnish |
| Pediagel1.23% Acidulated Phosphate Fluoride Gel | Device | Pediagel |
Primary outcome
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
Time frame: Baseline, Three and Six Month
Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Franklin Garcia-Godoy, DDS, MS principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanish Varnish and Pediagel in people with White Spot Lesions, run by Solventum US LLC at 1 site 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 6 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 2 Oct 2024. 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 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?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison (time frame: Baseline, Three and Six Month). 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 2 Oct 2024.