Omega-3 Fatty Acids in Chronic Periodontitis. (omega3)

November 24, 2013 updated by: GIRISH DEORE, Tatyasaheb Kore Dental College

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Kolhapur, Maharashtra, India, 416137
        • Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in serum CRP level at 6 weeks and 12 weeks
Time Frame: baseline, 6 weeks, 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
Time Frame: baseline, 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.
Time Frame: baseline, 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
Time Frame: baseline, 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
Time Frame: baseline, 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.
Time Frame: baseline, 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
Time Frame: baseline, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatyasaheb Kore Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 24, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 24, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKDC13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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