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Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

NCT ID: NCT02014532

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Periodontitis

Keywords

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Leukotriene receptor antagonist Chronic periodontitis Scaling and root planing C- reactive protein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Montelukast

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.

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Patients in Montelukast Group were treated with scaling and root planing (SRP) along with Montelukast (Montair 10mg), 1 tablet twice daily for 3 weeks.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients in Placebo Group were treated with scaling and root planing (SRP) along with Placebo therapy, 1 tablet twice daily for 3 weeks.

Interventions

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Montelukast

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

Placebo

Patients in Placebo Group were treated with scaling and root planing (SRP) along with Placebo therapy, 1 tablet twice daily for 3 weeks.

Intervention Type DRUG

Other Intervention Names

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Montair 10 mg (brand name) Leukotriene receptor antagonist.

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tatyasaheb Kore Dental College

OTHER

Sponsor Role lead

Responsible Party

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Dr.Saurabh Inamdar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saurabh P Inamdar, BDS

Role: PRINCIPAL_INVESTIGATOR

Post Graduate student

Locations

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Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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TKDC15

Identifier Type: -

Identifier Source: org_study_id