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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis

ClinicalTrials.gov ID: NCT03400475

Public ClinicalTrials.gov record NCT03400475. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis: A Pilot Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03400475
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Ahmed Mohamed Mahrous
Other
Enrollment
46 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 22, 2015
Primary completion
Oct 23, 2016
Completion
Oct 23, 2016
Last update posted
Dec 18, 2018

2015 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Iowa College of Dentistry and Dental Clinics Iowa City Iowa 52242

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03400475, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2018 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03400475 live on ClinicalTrials.gov.

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