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OpenTrials
Completed

NCT Number: NCT02372656

Simvastatin and Metformin in Chronic Periodontitis

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

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Gel

Drug

Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

Other names: Placebo group

1% Metformin

Drug

1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

Other names: 1% Metformin group

1.2% Simvastatin

Drug

1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

Other names: 1.2% Simvastatin group

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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