1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

NCT02060032 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2011-2012/B
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis. Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis, Local drug delivery,

Outcome Measures

Primary Outcomes (1)

• Change in Radiographic intra-bony defect depth.

  The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.

  9 months from baseline

Secondary Outcomes (4)

• Change in Probing depth.

  9 months from baseline

• Change in Relative attachment level

  9 months from baseline

• Change in mSBI (gingival index)

  9 months from baseline

• Change in plaque index

  9 months from baseline

Study Arms (3)

Atorvastatin

ACTIVE COMPARATOR

1.2% atorvastatin local drug delivery

Drug: 1.2% Atorvastatin local drug delivery

Simvastatin

SHAM COMPARATOR

1.2% simvastatin local drug delivery

Drug: 1.2% simvastatin local drug delivery

Placebo

PLACEBO COMPARATOR

Placebo local drug delivery

Drug: Placebo local drug delivery

Interventions

1.2% Atorvastatin local drug delivery DRUG

Atorvastatin

1.2% simvastatin local drug delivery DRUG

Simvastatin

Placebo local drug delivery DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months

You may not qualify if:

• Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Avani R Pradeep, MDS

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 11, 2014
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02