Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

Tatyasaheb Kore Dental College

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Drug: Placebo; Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT02014532

TKDC15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Montelukast

Active Comparator group

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.

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo