An interventional study of Vanish Varnish and Pediagel in White Spot Lesions, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment
Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.
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.
Solventum US LLC is the lead sponsor of 64 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1.23% Acidulated Phosphate Fluoride Gel
Device: Pediagel
5% sodium fluoride varnish
Device: Vanish Varnish
5% sodium fluoride varnish with tricalcium phosphate
1.23% Acidulated Phosphate Fluoride Gel
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.
Time frame: Baseline, Three and Six Month
| Milestone | Pediagel | Vanish Varnish |
|---|---|---|
| Started | 23 | 15 |
| Completed | 17 | 15 |
| Not completed | 6 | 0 |
| Withdrew: Lost to follow-up | 6 | 0 |
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.
| units on a scale | Pediagel | Vanish Varnish |
|---|---|---|
| Baseline | 5.10 ± 2.67 | 6.01 ± 4.17 |
| Three Months | 4.08 ± 2.32 | 5.50 ± 3.81 |
| Six Months | 3.52 ± 2.46 | 3.95 ± 2.97 |
Collected over Six Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 2 | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Group 1 | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Pediagel | Vanish Varnish | Total |
|---|---|---|---|
| <=18 years | 23 | 15 | 38 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Pediagel | Vanish Varnish | Total |
|---|---|---|---|
| Female | 11 | 8 | 19 |
| Male | 12 | 7 | 19 |
The record gives a start of Feb 2012, a primary completion of Mar 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2019, 4 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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