Simvastatin and Metformin in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372656
• Other study ID #: GDCRI/ACM/PG/PhD/10C/2013-14
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 30, 2014
• Last updated: February 20, 2015
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Placebo gel
Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
• 1% Metformin
1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
• 1.2% Simvastatin
1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in defect depth reduction from baseline to 6 months and from baseline to 9 months	Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.	Baseline to 6 months and Baseline to 9 months	No
Secondary	Plaque index will be measured at 3, 6 and 9 months		3,6 and 9 months	No
Secondary	Modified sulcular bleeding index at 3, 6 and 9 months		3 , 6 and 9 months	No
Secondary	Probing pocket depth at 3, 6 and 9 months		3 , 6 and 9 months	No
Secondary	Clinical attachment level at 3, 6 and 9 months		3 , 6 and 9 months	No