Back to resultsOmega-3 Fatty Acids in Chronic Periodontitis. (omega3)
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Omega 3 fatty acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Omega 3 fatty acids, C Reactive Protein, Host Modulation, Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tatyasaheb Kore Dental College and Research Centre, New Pargaon
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Test Group
Control Group
Arm Description
Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks
Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks
Outcomes
Primary Outcome Measures
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)
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
NCT ID
NCT01997853
First Posted
November 20, 2013
Last Updated
November 24, 2013
Sponsor
Tatyasaheb Kore Dental College
1. Study Identification
Unique Protocol Identification Number
NCT01997853
Brief Title
Omega-3 Fatty Acids in Chronic Periodontitis.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Omega 3 fatty acids, C Reactive Protein, Host Modulation, Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Omega 3 fatty acid
Other Intervention Name(s)
Mega-3
Intervention Description
Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks and SRP at baseline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks and SRP
Primary Outcome Measure Information:
Title
Change from baseline in serum CRP level at 6 weeks and 12 weeks
Description
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
Title
Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeks
Description
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
Title
Changes from baseline in Clinical Attachment Level (CAL) at 6 weeks and 12 weeks.
Description
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 Outcome Measure Information:
Title
Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeks
Description
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
Title
Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeks
Description
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
Title
Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks.
Description
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
Title
Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girish D Deore, BDS
Organizational Affiliation
Post Graduate Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatyasaheb Kore Dental College and Research Centre, New Pargaon
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416137
Country
India
12. IPD Sharing Statement
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Omega-3 Fatty Acids in Chronic Periodontitis.
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