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NCT01811316 · ClinicalTrials.gov registry record · NA
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
A NA study, sponsored by Sunstar Americas.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT01811316: Completed NA study, sponsored by Sunstar Americas.
NCT01811316 is a NA study that has completed, run by Sunstar Americas. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01811316, a NA study, has completed, sponsored by Sunstar Americas.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.
Primary Outcome
Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation) 1. Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit 2. Mild inflammation of the entire gingival unit 3. Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or
Interventions
- OTHER Probiotics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-03 |
| Phase | NA |
What the finished NCT01811316 record still lists
NCT01811316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Probiotics is the first listed.
NCT01811316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01811316 about?
NCT01811316 is a clinical study titled "A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis". The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.
What is the current status of trial NCT01811316?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2013-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01811316?
The interventions under investigation include: Probiotics (OTHER).
Who is sponsoring clinical trial NCT01811316?
This trial is sponsored by Sunstar Americas, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01811316's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 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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