Omega-3 Fatty Acids in Chronic Periodontitis.

Study Overview
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Brief Summary
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Omega 3 fatty acids is one such dietary supplement, known to modulate the host response in chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic cerebrovascular diseases, osteoporosis by producing Resolvins and protectins without showing any inadvertent effects.Addition of systemic Omega 3 Fatty Acids with SRP may enhance the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory properties. If proven, this can be used as a routine treatment modality.

Official Title
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Effect of Scaling & Root Planing (SRP) Combined With Therapy Of Omega-3 Fatty Acid on Clinical Parameters and Serum Levels of C-Reactive Protein (CRP) in Chronic Periodontitis - A Randomised Control Trial.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Omega 3 fatty acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 for 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, steroids or antibiotics / antimicrobials within September 2012 to August 2013, Confirmed or suspected intolerance to omega 3 fatty acids, Periodontal therapy done within the September 2012 to August 2013.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Group<br>Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks | Drug: Omega 3 fatty acid<br>* Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks and SRP at baseline<br>* Other names: Mega-3;|
| Placebo Comparator: Control Group<br>Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks | Drug: Placebo<br>* Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks and SRP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum CRP level at 6 weeks and 12 weeks | changes from baseline in biochemical parameter, serum CRP levels were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. Serum CRP level was measured in milligram/liter (mg/l) | baseline, 6 weeks, 12 weeks | 
| Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeks | changes from baseline in clinical parameter, PD were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. PD was measured in millimeter. | baseline, 6 weeks and 12 weeks | 
| Changes from baseline in Clinical Attachment Level (CAL) at 6 weeks and 12 weeks. | changes from baseline in clinical parameter, CAL were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. CAL was measured in millimeter. | baseline, 6 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeks | changes from baseline in standard clinical parameter, GI were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. GI has a scoring criteria specified by Silness & Loe, 1963. | baseline, 6 weeks and 12 weeks | 
| Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeks | changes from baseline in standard clinical parameter, PI were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. PI has a scoring criteria specified by Loe & Silness, 1964. | baseline, 6 weeks and 12 weeks | 
| Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks. | changes from baseline in standard clinical parameter, OHIS were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. OHIS has a scoring criteria specified by Greene and Vermilion, 1964. | baseline, 6 weeks and 12 weeks | 
| Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeks | changes from baseline in standard clinical parameter, SBI were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. SBI has a scoring criteria specified by Muhleman (1971). | baseline, 6 weeks and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega 3 fatty acids, C Reactive Protein, Host Modulation, Chronic Periodontitis