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Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Montelukast
Placebo
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Leukotriene receptor antagonist, Chronic periodontitis, Scaling and root planing, C- reactive protein

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients within age group of 30 to 55 years.
  2. Systemically healthy individuals.
  3. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria

Exclusion Criteria:

  1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy),
  2. Smoking,
  3. Chronic alcoholics,
  4. Pregnancy or lactation,
  5. Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013,
  6. Confirmed or suspected intolerance to Montelukast,
  7. Periodontal therapy done within the January 2012 to Jun 2013.

Sites / Locations

  • Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Montelukast

Placebo

Arm Description

Patients in Test Group were given Leukotriene receptor antagonist, Montelukast 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.

Patients in Control Group were given placebo drug 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.

Outcomes

Primary Outcome Measures

Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks
The biochemical parameter of serum C- reactive protein levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) the change in C- reactive protein levels was analysed.
Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks
The probing pocket depths were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in probing pocket depth was analysed.
Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.
The clinical attachment levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in clinical attachment levels was analysed.

Secondary Outcome Measures

Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks
changes from baseline in standard clinical parameter, GI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. GI has a scoring criteria specified by Silness & Loe, 1963.
Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks
changes from baseline in standard clinical parameter, PI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PI has a scoring criteria specified by Loe & Silness, 1964.
Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks
changes from baseline in standard clinical parameter, OHI-S were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. OHI-S has a scoring criteria specified by Greene and Vermilion, 1964.
Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks
changes from baseline in standard clinical parameter, SBI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. SBI has a scoring criteria specified by Muhleman (1971).

Full Information

First Posted
December 12, 2013
Last Updated
December 18, 2013
Sponsor
Tatyasaheb Kore Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT02014532
Brief Title
Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis
Official Title
The Effect Of SRP With Adjunctive Systemic Therapy Of Leukotriene Receptor Antagonist-Montelukast On The Serum C Reactive Protein Levels & Clinical Parameters In Chronic Periodontitis Patients - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and root planing in patients with chronic periodontitis leads to host inflammatory response modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open new vistas in treatment of chronic periodontitis.
Detailed Description
A RCT was carried out to check the efficacy of Montelukast as an adjunct to scaling and root planing. The patients were randomised to either test group (SRP + Montelukast) and control group (SRP). Clinical parameters were assessed at baseline, 3 weeks and 6 weeks. Serum C-reactive protein levels were assessed at baseline, 3 weeks and 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Leukotriene receptor antagonist, Chronic periodontitis, Scaling and root planing, C- reactive protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
Patients in Test Group were given Leukotriene receptor antagonist, Montelukast 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in Control Group were given placebo drug 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Montair 10 mg (brand name), Leukotriene receptor antagonist.
Intervention Description
Patients in Montelukast Group were treated with scaling and root planing (SRP) along with Montelukast (Montair 10mg), 1 tablet twice daily for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in Placebo Group were treated with scaling and root planing (SRP) along with Placebo therapy, 1 tablet twice daily for 3 weeks.
Primary Outcome Measure Information:
Title
Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks
Description
The biochemical parameter of serum C- reactive protein levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) the change in C- reactive protein levels was analysed.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks
Description
The probing pocket depths were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in probing pocket depth was analysed.
Time Frame
baseline, 3 weeks and 6 weeks.
Title
Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.
Description
The clinical attachment levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in clinical attachment levels was analysed.
Time Frame
baseline, 3 weeks and 6 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks
Description
changes from baseline in standard clinical parameter, GI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. GI has a scoring criteria specified by Silness & Loe, 1963.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks
Description
changes from baseline in standard clinical parameter, PI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PI has a scoring criteria specified by Loe & Silness, 1964.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks
Description
changes from baseline in standard clinical parameter, OHI-S were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. OHI-S has a scoring criteria specified by Greene and Vermilion, 1964.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks
Description
changes from baseline in standard clinical parameter, SBI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. SBI has a scoring criteria specified by Muhleman (1971).
Time Frame
baseline, 3 weeks and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients within age group of 30 to 55 years. Systemically healthy individuals. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria Exclusion Criteria: Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy), Smoking, Chronic alcoholics, Pregnancy or lactation, Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013, Confirmed or suspected intolerance to Montelukast, Periodontal therapy done within the January 2012 to Jun 2013.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saurabh P Inamdar, BDS
Organizational Affiliation
Post Graduate student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatyasaheb Kore Dental College and Research Centre, New Pargaon
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416137
Country
India

12. IPD Sharing Statement

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Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

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