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Completed

NCT Number: NCT02014532

Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

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.

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Key information

Conditions

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

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, 416137, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks

    Time frame: baseline, 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.

  2. Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks

    Time frame: baseline, 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.

  3. Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.

    Time frame: baseline, 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.

Secondary outcomes

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

    Time frame: baseline, 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.

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

    Time frame: baseline, 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.

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

    Time frame: baseline, 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.

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

    Time frame: baseline, 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).

Sponsors and collaborators

Lead sponsor

Tatyasaheb Kore Dental College

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 18, 2013
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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