Omega-3 Fatty Acids in Chronic Periodontitis.

Phase 4CompletedNCT01997853

Tatyasaheb Kore Dental College60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

Omega 3 fatty acidDRUG

Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks and SRP at baseline

PlaceboDRUG

Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks and SRP

Eligibility

Sex: ALLMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 for 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, steroids or antibiotics / antimicrobials within September 2012 to August 2013, 6. Confirmed or suspected intolerance to omega 3 fatty acids, 7. Periodontal therapy done within the September 2012 to August 2013.

Locations (1)

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, India

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 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.

Time frame: baseline, 6 weeks and 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: baseline, 6 weeks and 12 weeks

Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks.

Data from ClinicalTrials.gov

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