Clinical trial NCT01997853: Omega-3 Fatty Acids in Chronic Periodontitis.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Omega 3 fatty acids
C Reactive Protein
Host Modulation
Chronic Periodontitis
Lead sponsor: Tatyasaheb Kore Dental College
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in serum CRP level at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks, 12 weeks
measure: Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks and 12 weeks
measure: Changes from baseline in Clinical Attachment Level (CAL) at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks and 12 weeks
Secondary outcomes:
measure: Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks and 12 weeks
measure: Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks and 12 weeks
measure: Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks.
timeFrame: baseline, 6 weeks and 12 weeks
measure: Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeks
timeFrame: baseline, 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Kolhapur
country: India
facility: Tatyasaheb Kore Dental College and Research Centre, New Pargaon
state: Maharashtra
Study officials:
affiliation: Post Graduate Student
name: Girish D Deore, BDS
role: PRINCIPAL_INVESTIGATOR
References: