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NCT02617407 · ClinicalTrials.gov registry record · Phase 1
Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02617407: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT02617407 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02617407, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Children undergoing chemotherapy, radiation treatment and Hematopoietic Stem Cell Transplantation (HSCT) have significant difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective in reducing dental plaques while containing no additives found in other toothpastes that can cause increased gingival irritation. The investigators hypothesize that improved oral hygiene and better plaque control in pediatric patients receiving chemo/radiation treatment or HSCT may result in reduced oral inflammation, decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related systemic bacterial infections. The overall goal of this prospective randomized (2:1) pilot study is to determine whether incorporation of the Livionex® toothpaste in the research regimen could reduce dental plaque.
Primary Outcome
Compliance will be recorded two times daily, units on a scale 0 - 2 (2 = excellent compliance, 0 = no compliance). A mean score from day 1 to 7 will be compared (t-test) for each patient and between the treatment and the control group.
Interventions
- DRUG Livionex® Dental Gel
- DRUG PreviDent 5000 plus/Tom's of Maine Children's toothpaste
- DEVICE Kolibree Toothbrush
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-07-28 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 1 |
What the finished NCT02617407 record still lists
NCT02617407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Livionex® Dental Gel is the first listed.
NCT02617407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02617407 about?
NCT02617407 is a clinical study titled "Livionex Oral Microbiome and Dental Plaque Control in HSCT Recipients". Children undergoing chemotherapy, radiation treatment and Hematopoietic Stem Cell Transplantation (HSCT) have significant difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effe...
What is the current status of trial NCT02617407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2016-07-28. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT02617407?
The interventions under investigation include: Livionex® Dental Gel (DRUG), PreviDent 5000 plus/Tom's of Maine Children's toothpaste (DRUG), Kolibree Toothbrush (DEVICE).
Who is sponsoring clinical trial NCT02617407?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02617407's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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