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

• Status: Completed
• Trial end date: 2016-10-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ahmed Mohamed Mahrous
• Collaborators: American College of Prosthodontists Education Foundation; Greater New York Academy of Prosthodontics; University of Iowa
• Treatments: Pharmaceutical Solutions; Simvastatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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