Clinical trial NCT02014532: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Leukotriene receptor antagonist
Chronic periodontitis
Scaling and root planing
C- reactive protein
Lead sponsor: Tatyasaheb Kore Dental College
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks
timeFrame: baseline, 3 weeks and 6 weeks
measure: Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks
timeFrame: baseline, 3 weeks and 6 weeks.
measure: Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.
timeFrame: baseline, 3 weeks and 6 weeks
Secondary outcomes:
measure: Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks
timeFrame: baseline, 3 weeks and 6 weeks
measure: Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks
timeFrame: baseline, 3 weeks and 6 weeks
measure: Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks
timeFrame: baseline, 3 weeks and 6 weeks
measure: Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks
timeFrame: baseline, 3 weeks and 6 weeks
Other outcomes:
Locations:
city: Kolhapur
country: India
facility: Tatyasaheb Kore Dental College and Research Centre, New Pargaon
state: Maharashtra
Study officials:
affiliation: Post Graduate student
name: Saurabh P Inamdar, BDS
role: PRINCIPAL_INVESTIGATOR
References: