Phase 2 N=46 Randomized Triple-blind Treatment

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

Peri-implant Mucositis

Bottom Line

View on ClinicalTrials.gov: NCT03400475 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Change in Interleukin 1 B at Base to 24 Hours — -1.075; 1.013 Micrograms per deciliter (ug/dl) — p=0.90

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simvastatin (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ahmed Mohamed Mahrous
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Interleukin 1 B at Base to 24 Hours	-1.075; 1.013	0.90
PRIMARY Change in Interleukin 1 B at Base to 1 Week	2.5016; -1.095	0.90
PRIMARY Change in Interleukin 1 B 24 Hours - 1 Week	3.577; -2.108	0.90
PRIMARY Change in Interleukin 6 at Base to 24 Hours	0.118; 0.201	0.90
PRIMARY Change in Interleukin 6 Baseline to 1 Week	0.304; 0.275	0.90
PRIMARY Change in Interleukin 6 24 Hours - 1 Week	0.185; 0.073	0.90
PRIMARY Change in Interleukin 8 at Base to 24 Hours	0.00; 64.696	0.86
PRIMARY Change in Interleukin 8 at Base to 1 Week	131.368; 20.275	0.86
PRIMARY Change in Interleukin 8 24 Hours to 1 Week	168.894; -44.42	0.86
PRIMARY Change in Tumor Necrosis Factor Alpha at Base to 24 Hours	37.526; -0.17	0.41
PRIMARY Change in Tumor Necrosis Factor Alpha at Base to 1 Week	1.5833; -0.0704	0.41
PRIMARY Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week	1.641; 0.095	0.41
SECONDARY Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline	1; 0; 0; 0; 18; 12	0.071
SECONDARY Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours	1; 1; 16; 4; 6; 12	0.071
SECONDARY Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week	1; 1; 2; 1; 17; 17	1
SECONDARY Probing Depth Level (Averaged Over 6 Sites) at Baseline	0; 1; 3; 5; 9; 10	0.062
SECONDARY Probing Depth Level (Averaged Over 6 Sites) at 24 Hours	1; 0; 5; 5; 7; 10	0.54
SECONDARY Probing Depth Level (Averaged Over 6 Sites) at 1 Week	1; 0; 4; 4; 8; 13	0.34

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03400475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.