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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 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 38 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04528134
The ClinicalTrials.gov registry entry for NCT04528134 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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