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Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
NCT02342691 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02342691 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02342691?
The interventions under investigation include: BLXA4 (DRUG), Placebo oral rinse (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02342691?
This trial is sponsored by The Forsyth Institute, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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