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Trial record 18 of 312 for:    "Periodontitis, Chronic"

Omega-3 Fatty Acids in Chronic Periodontitis. (omega3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01997853
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
GIRISH DEORE, Tatyasaheb Kore Dental College

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Omega 3 fatty acid Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : November 2013

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Arm Intervention/treatment
Active Comparator: Test Group
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
Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks and SRP at baseline
Other Name: Mega-3

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




Primary Outcome Measures :
  1. Change from baseline in serum CRP level at 6 weeks and 12 weeks [ Time Frame: baseline, 6 weeks, 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)

  2. Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeks [ Time Frame: baseline, 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.

  3. Changes from baseline in Clinical Attachment Level (CAL) at 6 weeks and 12 weeks. [ Time Frame: baseline, 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 :
  1. Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeks [ Time Frame: baseline, 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.

  2. Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeks [ Time Frame: baseline, 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.

  3. Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks. [ Time Frame: baseline, 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.

  4. Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeks [ Time Frame: baseline, 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).



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997853


Locations
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India
Tatyasaheb Kore Dental College and Research Centre, New Pargaon
Kolhapur, Maharashtra, India, 416137
Sponsors and Collaborators
Tatyasaheb Kore Dental College
Investigators
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Principal Investigator: Girish D Deore, BDS Post Graduate Student

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Responsible Party: GIRISH DEORE, Principal Investigator, Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier: NCT01997853     History of Changes
Other Study ID Numbers: TKDC13
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by GIRISH DEORE, Tatyasaheb Kore Dental College:
Omega 3 fatty acids
C Reactive Protein
Host Modulation
Chronic Periodontitis

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases