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NCT03400475 · ClinicalTrials.gov registry record · Phase 2
Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis
A Phase 2 study of Peri-implant Mucositis, sponsored by Ahmed Mohamed Mahrous.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT03400475: Completed Phase 2 study of Peri-implant Mucositis, sponsored by Ahmed Mohamed Mahrous.
NCT03400475 is a Phase 2 study of Peri-implant Mucositis that has completed, run by Ahmed Mohamed Mahrous. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400475, a Phase 2 study of Peri-implant Mucositis, has completed, sponsored by Ahmed Mohamed Mahrous.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
This study seeks to test the recently discovered anti-inflammatory action of statins on inflamed mucosa surrounding dental implants. Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation. The pilot study will involve 44 subjects divided into a test and control group. The test group shall receive topical simvastatin gel administered around the implant with a blunt tipped needle. The control group will receive a placebo. Inflammatory state shall be determined at baseline as well as follow up visits at 24 hours, 1 week, and 1 month by clinical indices of inflammation as well as biochemical markers of inflammation gathered from around the implants.
Primary Outcome
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Simvastatin
Study Locations (1)
Iowa
- University of Iowa College of Dentistry and Dental Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-04-23 |
| Est. Completion | 2016-10-24 |
| Phase | Phase 2 |
What the finished NCT03400475 record still lists
NCT03400475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Peri-implant Mucositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03400475 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT03400475 about?
NCT03400475 is a clinical study titled "Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis". This study seeks to test the recently discovered anti-inflammatory action of statins on inflamed mucosa surrounding dental implants. Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation. The pilot study will involve 44 subjects divided into a test and control...
What is the current status of trial NCT03400475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2015-04-23. Estimated completion is 2016-10-24.
What conditions does trial NCT03400475 study?
This clinical trial studies the following conditions: Peri-implant Mucositis.
What interventions are being tested in trial NCT03400475?
The interventions under investigation include: Placebo (OTHER), Simvastatin (DRUG).
Who is sponsoring clinical trial NCT03400475?
This trial is sponsored by Ahmed Mohamed Mahrous, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03400475 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03400475's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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