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CompletedNCT01997853omega3Updated Nov 28, 2013

Omega-3 Fatty Acids in Chronic Periodontitis.

A Phase 4 interventional study of Omega 3 fatty acid and Placebo in Chronic Periodontitis, sponsored by Tatyasaheb Kore Dental College. Completed at 1 site in India. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by Tatyasaheb Kore Dental College · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Periodontitis

Keywords

  • Omega 3 fatty acids
  • C Reactive Protein
  • Host Modulation
  • Chronic Periodontitis
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Tatyasaheb Kore Dental College is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Control Group

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

    Drug: Placebo

Interventions

  • DrugOmega 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

    Also known as: Mega-3

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

  3. 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.

    Time frame: baseline, 6 weeks and 12 weeks

  4. 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).

    Time frame: baseline, 6 weeks and 12 weeks

07

Study locations

1 site
  • Tatyasaheb Kore Dental College and Research Centre, New Pargaon
    Kolhapur, Maharashtra 416137, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01997853
Lead sponsor
Tatyasaheb Kore Dental College
Responsible party
GIRISH DEORE (Principal Investigator, Tatyasaheb Kore Dental College) — Principal investigator
First posted
Nov 28, 2013
Start date
Jul 2012
Primary completion
Aug 2013
Completion
Nov 2013
Last update
Nov 28, 2013

Study contacts

Girish D Deore, BDS
principal investigator · Post Graduate Student

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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