Omega-3 Fatty Acids in Chronic Periodontitis.

Chronic Periodontitis Clinical Trial

— omega3  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997853
• Other study ID #: TKDC13
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2013
• Last updated: November 24, 2013
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Tatyasaheb Kore Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
India	Tatyasaheb Kore Dental College and Research Centre, New Pargaon	Kolhapur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tatyasaheb Kore Dental College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	baseline, 6 weeks and 12 weeks	No
Secondary	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.	baseline, 6 weeks and 12 weeks	No
Secondary	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.	baseline, 6 weeks and 12 weeks	No
Secondary	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).	baseline, 6 weeks and 12 weeks	No