Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

NCT02014532 | Completed Phase 4 DMC

• 1 other identifier: TKDC15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Leukotriene receptor antagonist; Chronic periodontitis; Scaling and root planing; C- reactive protein

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

• 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

Secondary Outcomes (4)

• Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

• Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

• Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

• Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

Study Arms (2)

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.

Drug: Montelukast

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.

Drug: Placebo

Interventions

Montelukast DRUG

Patients in Montelukast Group were treated with scaling and root planing (SRP) along with Montelukast (Montair 10mg), 1 tablet twice daily for 3 weeks.

Also known as: Montair 10 mg (brand name), Leukotriene receptor antagonist.

Montelukast

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, 416137, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

montelukast; Leukotriene Antagonists

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Saurabh P Inamdar, BDS

  Post Graduate student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

IN (1)