Simvastatin and Metformin in Chronic Periodontitis

NCT02372656 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/10C/2013-14
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Periodontitis

Keywords

Simvastatin, Metformin, Chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Plaque index will be measured at 3, 6 and 9 months

  3,6 and 9 months

• Modified sulcular bleeding index at 3, 6 and 9 months

  3 , 6 and 9 months

• Probing pocket depth at 3, 6 and 9 months

  3 , 6 and 9 months

• Clinical attachment level at 3, 6 and 9 months

  3 , 6 and 9 months

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.

Drug: Placebo gel

1% Metformin

ACTIVE COMPARATOR

1% metformin gel to be delivered at baseline, 3, 6 and 9 months.

Drug: 1% Metformin

1.2% Simvastatin

ACTIVE COMPARATOR

1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.

Drug: 1.2% Simvastatin

Interventions

Placebo gel DRUG

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

Also known as: Placebo group

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.

Also known as: 1% Metformin group

1% Metformin

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.

Also known as: 1.2% Simvastatin group

1.2% Simvastatin

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Metformin; Simvastatin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: February 26, 2015
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 26, 2015

Record last verified: 2015-02