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NCT01103102 · ClinicalTrials.gov registry record · Phase 2
Dose-Response Study of Iocide Oral Rinse
A Phase 2 study of Gingivitis, sponsored by Biomedical Development Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT01103102: Completed Phase 2 study of Gingivitis, sponsored by Biomedical Development Corporation.
NCT01103102 is a Phase 2 study of Gingivitis that has completed, run by Biomedical Development Corporation. The registered enrollment target is 97 participants, below the 233-participant average among 25 other Gingivitis trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103102, a Phase 2 study of Gingivitis, has completed, sponsored by Biomedical Development Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to explore the dose-response relationship of Iocide oral rinse in a clinical trial of gingivitis. Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into the 3-month study to provide 40 total evaluable subjects (10 per group). Each study participant will have four visits: a screening visit up to 21 days before the beginning of the trial, a baseline visit at day 1, and visits at weeks 8 and 12. The duration of the dose/range study will be three months to facilitate compliance and ensure timely completion of the Phase II study. Three dose/regimens will be evaluated against a placebo control oral rinse. Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine the effect of the antimicrobial oral rinse on relative levels of biological markers of inflammation.
Primary Outcome
The primary outcome measure will be the mean gingival index (GI) score.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Iocide Oral Rinse
Study Locations (1)
Texas
- University of Texas Health Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01103102 record still lists
NCT01103102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 233-participant average among 25 other Gingivitis trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Gingivitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01103102 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01103102 about?
NCT01103102 is a clinical study titled "Dose-Response Study of Iocide Oral Rinse". The purpose of this study is to explore the dose-response relationship of Iocide oral rinse in a clinical trial of gingivitis. Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into the 3-month study to provide 40 total evaluable subjects (10 per group). Each ...
What is the current status of trial NCT01103102?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2010-04. Estimated completion is 2012-04.
What conditions does trial NCT01103102 study?
This clinical trial studies the following conditions: Gingivitis.
What interventions are being tested in trial NCT01103102?
The interventions under investigation include: Placebo (DRUG), Iocide Oral Rinse (DRUG).
Who is sponsoring clinical trial NCT01103102?
This trial is sponsored by Biomedical Development Corporation, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01103102 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gingivitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01103102's enrollment target sits among peer trials
97 13th of 25 higher than 13 of 25 other Gingivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gingivitis 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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