Omega-3 Fatty Acids in Chronic Periodontitis.

NCT ID: NCT01997853

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-11-30

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.

Detailed Description

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Conditions

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Chronic Periodontitis

Keywords

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Omega 3 fatty acids C Reactive Protein Host Modulation Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Test Group

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

Group Type ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type DRUG

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

Control Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Omega 3 fatty acid

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Mega-3

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tatyasaheb Kore Dental College

OTHER

Sponsor Role lead

Responsible Party

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GIRISH DEORE

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Girish D Deore, BDS

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Student

Locations

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Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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TKDC13

Identifier Type: -

Identifier Source: org_study_id