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Completed

NCT Number: NCT01997853

Omega-3 Fatty Acids in Chronic Periodontitis.

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, 416137, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega 3 fatty acid

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

Other names: Mega-3

Placebo

Drug

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Tatyasaheb Kore Dental College

Other

Registry information

Official study title

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.

Acronym: omega3

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
Nov 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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