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Trial record 22 of 312 for:    "Periodontitis, Chronic"

Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02014532
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
Dr.Saurabh Inamdar, Tatyasaheb Kore Dental College

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Montelukast Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014532


Locations
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India
Tatyasaheb Kore Dental College and Research Centre, New Pargaon
Kolhapur, Maharashtra, India, 416137
Sponsors and Collaborators
Tatyasaheb Kore Dental College
Investigators
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Principal Investigator: Saurabh P Inamdar, BDS Post Graduate student

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Responsible Party: Dr.Saurabh Inamdar, Principal Investigator, Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier: NCT02014532     History of Changes
Other Study ID Numbers: TKDC15
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Dr.Saurabh Inamdar, Tatyasaheb Kore Dental College:
Leukotriene receptor antagonist
Chronic periodontitis
Scaling and root planing
C- reactive protein

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Montelukast
Leukotriene Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action