Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

NCT02600520 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014X
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in intrabony defect depth from baseline to 6 months

  Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured

  Baseline to 6 months

Secondary Outcomes (4)

• Change in plaque index (PI) from baseline to 6 months

  Baseline to 6 months

• Change in modified sulcus bleeding index (mSBI) from baseline to 6 months

  Baseline to 6 months

• Change in probing depth (PD) from baseline to 6 months

  Baseline to 6 months

• Change in clinical attachment (CA) level from baseline to 6 months

  Baseline to 6 months

Study Arms (3)

Rosuvastatin Group

ACTIVE COMPARATOR

SRP followed by RSV gel LDD

Drug: SRP with RSV gel LDD

Atorvastatin Group

ACTIVE COMPARATOR

SRP followed by ATV gel LDD

Drug: SRP with ATV gel LDD

Placebo group

PLACEBO COMPARATOR

SRP followed by placebo gel LDD

Drug: SRP with placebo gel LDD

Interventions

SRP with RSV gel LDD DRUG

After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket

Rosuvastatin Group

SRP with ATV gel LDD DRUG

After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket

Atorvastatin Group

SRP with placebo gel LDD DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

Placebo group

Eligibility Criteria

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

You may qualify if:

• Systemically healthy patients with PD ≥5mm or CA loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

You may not qualify if:

• Patients with a known systemic disease;
• known or suspected allergy to statin group;
• on systemic statin therapy;
• with aggressive periodontitis;
• who used tobacco in any form;
• alcoholics;
• immunocompromised patients;
• pregnant or lactating females were excluded from the study

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 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 & Head, Department of Periodontology

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11