Omega-3 Fatty Acids in Chronic Periodontitis.

NCT01997853 | Completed Phase 4 DMC

• 1 other identifier: TKDC13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

  baseline, 6 weeks, 12 weeks

• 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.

  baseline, 6 weeks and 12 weeks

• 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.

  baseline, 6 weeks and 12 weeks

Secondary Outcomes (4)

• Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeks

  baseline, 6 weeks and 12 weeks

• Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeks

  baseline, 6 weeks and 12 weeks

• Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks.

  baseline, 6 weeks and 12 weeks

• Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeks

  baseline, 6 weeks and 12 weeks

Study Arms (2)

Test Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

Also known as: Mega-3

Test Group

Placebo DRUG

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

Control Group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, 416137, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Girish D Deore, BDS

  Post Graduate Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: November 28, 2013
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

IN (1)