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NCT04528134 · ClinicalTrials.gov registry record · NA
Orthodontic Varnish Microbiology Study
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04528134: Completed NA study, sponsored by University of California, Los Angeles.
NCT04528134 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04528134, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Our study aims to investigate the efficacy of different commercially available fluoride varnishes to treat these white spot lesions after the completion of orthodontic treatment and evaluate their effect on the oral microbiome. Target enrollment is 120 subjects. The study will follow a split-mouth design, with each subject receiving different treatment on the left and right sides of their mouth. The subjects will be randomized into 3 groups, with each group receiving two of the following three options: placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer light-cured fluoride varnish. There will be 4 total visits for this study: Baseline (day 0): Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied T1 (day 30): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T2 (day 90): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T3 (day 180): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, dental cleaning performed Participants will be instructed to use regular fluoridated toothpaste and floss twice per day for the duration of the study.
Primary Outcome
Assessed change in severity of white spots on the teeth as measured by the DiagnoDent, which uses quantitative light-induced fluorescence to assess the depth/severity of enamel demineralization. The DiagnoDent gives a score from 0-100, with 100 indicating the most demineralization (worse outcome) and 0 indicating the least demineralization (best outcome).
Interventions
- DEVICE Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish
- DEVICE 5% Sodium Fluoride Varnish
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-02-07 |
| Est. Completion | 2025-07-01 |
| Phase | NA |
What the finished NCT04528134 record still lists
NCT04528134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish is the first listed.
NCT04528134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04528134 about?
NCT04528134 is a clinical study titled "Orthodontic Varnish Microbiology Study". Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Our study aims to i...
What is the current status of trial NCT04528134?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2022-02-07. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT04528134?
The interventions under investigation include: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish (DEVICE), 5% Sodium Fluoride Varnish (DEVICE).
Who is sponsoring clinical trial NCT04528134?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04528134's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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