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

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ClinicalTrials.gov Identifier: NCT03400475
Recruitment Status : Completed
First Posted : January 17, 2018
Results First Posted : November 29, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
Greater New York Academy of Prosthodontics
American College of Prosthodontists Education Foundation
University of Iowa
Information provided by (Responsible Party):
Ahmed Mohamed Mahrous, University of Iowa

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 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.


Condition or disease Intervention/treatment Phase
Peri-implant Mucositis Drug: Simvastatin Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Only the study coordinator will know whether the intervention is simvastatin or control.
Primary Purpose: Treatment
Official Title: The Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis: A Pilot Study
Actual Study Start Date : April 23, 2015
Actual Primary Completion Date : October 24, 2016
Actual Study Completion Date : October 24, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin group (Treatment)
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Drug: Simvastatin
One topical application in peri-implant gingival crevice
Other Name: Simvastatin Powder U.S.P.

Placebo Comparator: Control group
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
Other: Placebo
One topical application in peri-implant gingival crevice
Other Names:
  • Lecithin/isopropyl palmitate solution, Poloxamer 407 gel
  • Lipoil®, Polox Gel 20%®




Primary Outcome Measures :
  1. Change in Interleukin 1 B at Base to 24 Hours [ Time Frame: Baseline- 24hrs ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  2. Change in Interleukin 1 B at Base to 1 Week [ Time Frame: Baseline - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  3. Change in Interleukin 1 B 24 Hours - 1 Week [ Time Frame: 24 hours - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  4. Change in Interleukin 6 at Base to 24 Hours [ Time Frame: Baseline - 24 hours ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  5. Change in Interleukin 6 Baseline to 1 Week [ Time Frame: Baseline - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  6. Change in Interleukin 6 24 Hours - 1 Week [ Time Frame: 24 hours - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  7. Change in Interleukin 8 at Base to 24 Hours [ Time Frame: Baseline - 24 hours ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  8. Change in Interleukin 8 at Base to 1 Week [ Time Frame: Baseline - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  9. Change in Interleukin 8 24 Hours to 1 Week [ Time Frame: 24 hours - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  10. Change in Tumor Necrosis Factor Alpha at Base to 24 Hours [ Time Frame: Baseline- 24hrs ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  11. Change in Tumor Necrosis Factor Alpha at Base to 1 Week [ Time Frame: Baseline - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)

  12. Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week [ Time Frame: 24hrs - 1 week ]
    Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)


Secondary Outcome Measures :
  1. Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline [ Time Frame: Baseline ]

    Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:

    0= normal gingival without signs of inflammation, no inflammation, no bleeding

    1. minor inflammation , slight discoloration, minor surface alterations, no bleeding
    2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure
    3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.

  2. Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours [ Time Frame: 24 hours ]

    Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:

    0= normal gingival without signs of inflammation, no inflammation, no bleeding

    1. minor inflammation , slight discoloration, minor surface alterations, no bleeding
    2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure
    3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.

  3. Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week [ Time Frame: 1 week ]

    Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:

    0= normal gingival without signs of inflammation, no inflammation, no bleeding

    1. minor inflammation , slight discoloration, minor surface alterations, no bleeding
    2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure
    3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.

  4. Probing Depth Level (Averaged Over 6 Sites) at Baseline [ Time Frame: Baseline ]

    Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.

    probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.


  5. Probing Depth Level (Averaged Over 6 Sites) at 24 Hours [ Time Frame: 24 hours ]

    Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.

    probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.


  6. Probing Depth Level (Averaged Over 6 Sites) at 1 Week [ Time Frame: 1 week ]

    Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.

    probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400475


Locations
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United States, Iowa
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Ahmed Mohamed Mahrous
Greater New York Academy of Prosthodontics
American College of Prosthodontists Education Foundation
University of Iowa
Investigators
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Principal Investigator: Ahmed M Mahrous, B.D.S., M.S. University of Iowa College of Dentistry and Dental Clinics
  Study Documents (Full-Text)

Documents provided by Ahmed Mohamed Mahrous, University of Iowa:
Study Protocol  [PDF] August 30, 2014


Publications:

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Responsible Party: Ahmed Mohamed Mahrous, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03400475     History of Changes
Other Study ID Numbers: 201410714
First Posted: January 17, 2018    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: December 18, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ahmed Mohamed Mahrous, University of Iowa:
topical
subgingival
simvastatin

Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors