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Trial record 1 of 312 for:    "Periodontitis, Chronic"
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Simvastatin and Metformin in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02372656
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Placebo gel Drug: 1% Metformin Drug: 1.2% Simvastatin Phase 2 Phase 3

Detailed Description:

Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.

Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software

Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.

Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial
Study Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Group
Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.
Drug: Placebo gel
Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other Name: Placebo group

Active Comparator: 1% Metformin
1% metformin gel to be delivered at baseline, 3, 6 and 9 months.
Drug: 1% Metformin
1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other Name: 1% Metformin group

Active Comparator: 1.2% Simvastatin
1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.
Drug: 1.2% Simvastatin
1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other Name: 1.2% Simvastatin group




Primary Outcome Measures :
  1. Change in defect depth reduction from baseline to 6 months and from baseline to 9 months [ Time Frame: Baseline to 6 months and Baseline to 9 months ]
    Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.


Secondary Outcome Measures :
  1. Plaque index will be measured at 3, 6 and 9 months [ Time Frame: 3,6 and 9 months ]
  2. Modified sulcular bleeding index at 3, 6 and 9 months [ Time Frame: 3 , 6 and 9 months ]
  3. Probing pocket depth at 3, 6 and 9 months [ Time Frame: 3 , 6 and 9 months ]
  4. Clinical attachment level at 3, 6 and 9 months [ Time Frame: 3 , 6 and 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systemically healthy subjects
  • Pocket depth ≥ 5 mm
  • Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months

Exclusion Criteria:

  • Subjects allergic to MF or SMV
  • Those on systemic MF or SMV therapy
  • Subjects with aggressive periodontitis
  • Immunocompromised subjects
  • Use of tobacco in any form, alcoholics
  • Lactating and pregnant females

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Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02372656     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/10C/2013-14
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
Simvastatin, Metformin, Chronic periodontitis

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metformin
Simvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors