Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014532
• Other study ID #: TKDC15
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2013
• Last updated: December 18, 2013
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: Tatyasaheb Kore Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
India	Tatyasaheb Kore Dental College and Research Centre, New Pargaon	Kolhapur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tatyasaheb Kore Dental College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks	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.	baseline, 3 weeks and 6 weeks	No
Primary	Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks	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.	baseline, 3 weeks and 6 weeks.	No
Primary	Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.	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.	baseline, 3 weeks and 6 weeks	No
Secondary	Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks	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.	baseline, 3 weeks and 6 weeks	No
Secondary	Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks	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.	baseline, 3 weeks and 6 weeks	No
Secondary	Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks	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.	baseline, 3 weeks and 6 weeks	No
Secondary	Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks	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).	baseline, 3 weeks and 6 weeks	No