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

Completed · Phase 2 · Has a placebo group

Conditions studied: Peri-implant Mucositis

In brief

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.

Key facts

Study ID

NCT03400475

Run by

Ahmed Mohamed Mahrous

People needed

46

Starts

2015-04-23

Expected to finish

2016-10-24

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Read, understand, and sign the informed consent forms
• Have at least 1 dental implant
• Have no evidence of peri-implantitis as evidenced by mesial and distal bone loss more than 1 mm from the accepted reference point round the implants on the periapical radiograph
• Demonstrate peri-implant mucositis as evidenced by bleeding on probing with 0.25 N/cm

You may not qualify if…

• Have allergic reactions to simvastatin
• Have peri-implantitis as evidenced by more than 1 mm of mesial and distal bone loss from an accepted reference point on the implants on the periapical radiograph
• Demonstrate no bleeding on probing with 0.25 N/ cm
• Have uncontrolled systemic disease
• Pregnancy or females who suspect/may be pregnant, as well as nursing and breast feeding mothers
• Take statin / HMG-CoA reductase inhibitor medications
• Smokers
• Require antibiotic prophylaxis
• Take anti-inflammatory medication, immunosuppressive medications or immunosuppressed patients
• Have paraben allergies
• Have soybean allergies

Where it is running

• University of Iowa College of Dentistry and Dental Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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