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NCT02342691 · ClinicalTrials.gov registry record · Phase 1
Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
A Phase 1 study of Gingival Inflammation, sponsored by The Forsyth Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT02342691 is a Phase 1 study of Gingival Inflammation that has completed, run by The Forsyth Institute. The registered enrollment target is 127 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02342691, a Phase 1 study of Gingival Inflammation, has completed, sponsored by The Forsyth Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by the incidence of adverse events, including mucosal inflammation and irritancy and findings from safety labs. Subjects will be monitored for development of periodontitis, and oral flora will be analyzed to detect an increase in opportunistic organisms. The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP) and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF). The study comprises three groups in a randomized, placebo-controlled double-blind clinical trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group will each include 50 subjects. The no-rinse control group will consist of 25 subjects. Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or placebo) to be applied once daily after morning teeth brushing. Safety parameters will be assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be assessed before and after 14 and 28 days of treatment.
Conditions Studied
Interventions
- DRUG BLXA4
- DRUG Placebo oral rinse
Study Locations (1)
Massachusetts
- The Forsyth Institute - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02342691
The ClinicalTrials.gov registry entry for NCT02342691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Forsyth Institute, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gingival Inflammation appearing as the primary indexed condition, and to 2 interventions - of which BLXA4 is the first listed.
NCT02342691 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02342691 about?
NCT02342691 is a clinical study titled "Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis". The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by the incidence of adverse events, including mucosal inflammation and irritancy and findings from safety labs. Subject...
What is the current status of trial NCT02342691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2015-04. Estimated completion is 2019-08-30.
What conditions does trial NCT02342691 study?
This clinical trial studies the following conditions: Gingival Inflammation.
What interventions are being tested in trial NCT02342691?
The interventions under investigation include: BLXA4 (DRUG), Placebo oral rinse (DRUG).
Who is sponsoring clinical trial NCT02342691?
This trial is sponsored by The Forsyth Institute, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02342691 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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