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

NCT03400475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-12-19

Study results available
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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.

Conditions

  • Peri-implant Mucositis

Interventions

DRUG

Simvastatin

One topical application in peri-implant gingival crevice

OTHER

Placebo

One topical application in peri-implant gingival crevice

Sponsors & Collaborators

  • Greater New York Academy of Prosthodontics

    collaborator UNKNOWN

  • American College of Prosthodontists Education Foundation

    collaborator UNKNOWN

  • University of Iowa

    collaborator OTHER

  • Ahmed Mohamed Mahrous

    lead OTHER

Principal Investigators

  • Ahmed M Mahrous, B.D.S., M.S. · University of Iowa College of Dentistry and Dental Clinics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-23
Primary Completion
2016-10-24
Completion
2016-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400475 on ClinicalTrials.gov