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Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.

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ClinicalTrials.gov Identifier: NCT03745300
Recruitment Status : Completed
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Wth Diabetes Mellitus Drug: ATORVASTATIN Drug: SIMVASTATIN Drug: PLACEBO Phase 2 Phase 3

Detailed Description:
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GROUP 1
Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery
Drug: ATORVASTATIN
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
Other Name: ATV

Active Comparator: GROUP 2
Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery
Drug: SIMVASTATIN
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
Other Name: SMV

Placebo Comparator: GROUP 3
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Drug: PLACEBO
Scaling and Root Planing (SRP) followed by placement of placebo gel
Other Name: inactive drug




Primary Outcome Measures :
  1. change in defect depth [ Time Frame: 6 and 9 months ]
    assessed in percentage


Secondary Outcome Measures :
  1. change in probing depth (PD) [ Time Frame: baseline, 6 and 9 months ]
  2. change in Clinical Attachment Level (CAL) [ Time Frame: baseline, 6 and 9 months ]
  3. CHANGE IN Plaque Index (PI) [ Time Frame: baseline, 6 and 9 months ]
  4. change in modified Sulcus Bleding Index (mSBI) [ Time Frame: baseline, 6 and 9 months ]


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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPAR] after phase I therapy

Exclusion Criteria:

  • 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745300


Locations
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India
Department of Periodontics, GDCRI Bangalore
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Investigators
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Principal Investigator: Avani R Pradeep, MDS GDCRI, Bangalore, INDIA

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Responsible Party: Dr. A R Pradeep, professor and HOD, Department of periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT03745300     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/Ph.D/5/2016-2017H
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Diabetes Mellitus
Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Atorvastatin
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors