Status:
COMPLETED
Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis
Lead Sponsor:
Ahmed Mohamed Mahrous
Collaborating Sponsors:
Greater New York Academy of Prosthodontics
American College of Prosthodontists Education Foundation
Conditions:
Peri-implant Mucositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Following signing the consent document the following will occur: 1. Screening Patients will complete standard medical and dental health history forms, followed by a study specific screening questionn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03400475
Start Date
April 23 2015
End Date
October 24 2016
Last Update
December 19 2018
Active Locations (1)
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1
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, United States, 52242