Trial | NCT02014532  Report issue

Title

Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    montelukast ...

  • Study Participants

    60
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.
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.
Study Started
Mar 31
2012
Primary Completion
Jul 31
2013
Study Completion
Oct 31
2013
Last Update
Dec 19
2013
Estimate

Drug 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.

  • Other names: Montair 10 mg (brand name), Leukotriene receptor antagonist.

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.

Montelukast Active Comparator

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.

Placebo Placebo Comparator

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.

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.
No Results Posted