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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saurabh P Inamdar, BDS | Post Graduate student | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tatyasaheb Kore Dental College and Research Centre, New Pargaon | Kolhāpur | Maharashtra | 416137 | India |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D020024 | Leukotriene Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| 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. |
|
| 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 |
| 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 |
| 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 |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |