Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis | RxWiki

Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Chronic Periodontitis
Intervention	Drug: Montelukast Drug: Placebo
Phase	Phase 4
Sponsor	Tatyasaheb Kore Dental College
Responsible Party	Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier	NCT02014532
First Received	December 12, 2013
Last Updated	December 18, 2013
Last verified	December 2013

Tracking Information[ + expand ][ + ]

First Received Date	December 12, 2013
Last Updated Date	December 18, 2013
Start Date	March 2012
Estimated Primary Completion Date	October 2013
Current Primary Outcome Measures	Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks [Time Frame: baseline, 3 weeks and 6 weeks] [Designated as safety issue: No]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 [Time Frame: baseline, 3 weeks and 6 weeks.] [Designated as safety issue: No]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. [Time Frame: baseline, 3 weeks and 6 weeks] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks [Time Frame: baseline, 3 weeks and 6 weeks] [Designated as safety issue: No]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 [Time Frame: baseline, 3 weeks and 6 weeks] [Designated as safety issue: No]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 [Time Frame: baseline, 3 weeks and 6 weeks] [Designated as safety issue: No]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 [Time Frame: baseline, 3 weeks and 6 weeks] [Designated as safety issue: No]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).

Descriptive Information[ + expand ][ + ]

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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Chronic Periodontitis
Intervention	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.
Study Arm (s)	Active Comparator: 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. Placebo Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	60
Estimated Completion Date	October 2013
Estimated Primary Completion Date	July 2013
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.
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT02014532
Other Study ID Numbers	TKDC15
Has Data Monitoring Committee	Yes
Information Provided By	Tatyasaheb Kore Dental College
Study Sponsor	Tatyasaheb Kore Dental College
Collaborators	Not Provided
Investigators	Principal Investigator: Saurabh P Inamdar, BDS Post Graduate student
Verification Date	December 2013

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