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Omega-3 Fatty Acids in Chronic Periodontitis.

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01997853
Acronym
omega3
Enrollment
60
Registered
2013-11-28
Start date
2012-07-31
Completion date
2013-11-30
Last updated
2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

Omega 3 fatty acids, C Reactive Protein, Host Modulation, Chronic Periodontitis

Brief 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.

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

DRUGPlacebo

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

Sponsors

Tatyasaheb Kore Dental College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in serum CRP level at 6 weeks and 12 weeksbaseline, 6 weeks, 12 weekschanges 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)
Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeksbaseline, 6 weeks and 12 weekschanges 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.
Changes from baseline in Clinical Attachment Level (CAL) at 6 weeks and 12 weeks.baseline, 6 weeks and 12 weekschanges 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

MeasureTime frameDescription
Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeksbaseline, 6 weeks and 12 weekschanges 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.
Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeksbaseline, 6 weeks and 12 weekschanges 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).
Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeksbaseline, 6 weeks and 12 weekschanges 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.
Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks.baseline, 6 weeks and 12 weekschanges 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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026