CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Simvastatin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03400475
NCT03400475Phase 2Completed
CompareCT.gov

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

Ahmed Mohamed Mahrous·interventional·Posted Jan 17, 2018·Updated Dec 19, 2018

In Brief

A Phase 2 clinical trial evaluating Simvastatin and Placebo for Peri-implant Mucositis. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeri-implant Mucositis
CountriesUnited States
CollaboratorsGreater New York Academy of Prosthodontics, American College of Prosthodontists Education Foundation, University of Iowa

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 17, 2018
Enrollment StartApr 23, 2015
Primary CompletionOct 24, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.5 years ago

Interventions

Simvastatindrug

One topical application in peri-implant gingival crevice

Placeboother

One topical application in peri-implant gingival crevice