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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.

Primary Purpose

Chronic Periodontitis Wth Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
ATORVASTATIN
SIMVASTATIN
PLACEBO
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis Wth Diabetes Mellitus

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Periodontics, GDCRI Bangalore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

GROUP 1

GROUP 2

GROUP 3

Arm Description

Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery

Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery

Scaling and root planing (SRP) followed by placebo gel local drug delivery

Outcomes

Primary Outcome Measures

change in defect depth
assessed in percentage

Secondary Outcome Measures

change in probing depth (PD)
change in Clinical Attachment Level (CAL)
CHANGE IN Plaque Index (PI)
change in modified Sulcus Bleding Index (mSBI)

Full Information

First Posted
November 2, 2018
Last Updated
November 15, 2018
Sponsor
Government Dental College and Research Institute, Bangalore
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1. Study Identification

Unique Protocol Identification Number
NCT03745300
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore

4. Oversight

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

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis Wth Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1
Arm Type
Active Comparator
Arm Description
Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery
Arm Title
GROUP 2
Arm Type
Active Comparator
Arm Description
Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery
Arm Title
GROUP 3
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Intervention Type
Drug
Intervention Name(s)
ATORVASTATIN
Other Intervention Name(s)
ATV
Intervention Description
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
Intervention Type
Drug
Intervention Name(s)
SIMVASTATIN
Other Intervention Name(s)
SMV
Intervention Description
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
inactive drug
Intervention Description
Scaling and Root Planing (SRP) followed by placement of placebo gel
Primary Outcome Measure Information:
Title
change in defect depth
Description
assessed in percentage
Time Frame
6 and 9 months
Secondary Outcome Measure Information:
Title
change in probing depth (PD)
Time Frame
baseline, 6 and 9 months
Title
change in Clinical Attachment Level (CAL)
Time Frame
baseline, 6 and 9 months
Title
CHANGE IN Plaque Index (PI)
Time Frame
baseline, 6 and 9 months
Title
change in modified Sulcus Bleding Index (mSBI)
Time Frame
baseline, 6 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avani R Pradeep, MDS
Organizational Affiliation
GDCRI, Bangalore, INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontics, GDCRI Bangalore
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India

12. IPD Sharing Statement

Learn more about this trial

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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