Effect of Omega 3 on Periodontitis in Postmenopausal Women

Study Overview
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Brief Summary
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The study was aimed to investigating changes in periodontal parameters and superoxide dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3 FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in postmenopausal women.

Detailed Description
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Fifty postmenopausal women with chronic periodontitis were divided randomly into two groups: Group 1 (n=25) were provided periodontal treatment in the form of scaling and root planing (SRP) plus placebo soft gelatin capsules while group 2 (n=25): patients were received SRP along with systemic administration of Omega 3 fatty acids. Clinical parameters and superoxide dismutase (SOD) activity in the gingival crevicular fluid were recorded at baseline, 3 and 6 months after therapy. The research has been conducted between July 2014 and June 2015. By the end of the study period, the Omega 3 treated group was able to achieve a greater mean probing pocket depth reduction, mean gain in clinical attachment level, as well as greater increase in SOD activity (P<0.01) compared to SRP alone.

Official Title
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Effect of Omega 3 Fatty Acids on Chronic Periodontitis Patients in Postmenopausal Women: A Randomized Controlled Clinical Study

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Dietary Supplement: Omega 3 fatty acids
* Procedure: scaling and root planing
* Other: placebo soft gelatin capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women with generalized chronic periodontitis (clinical attachment loss more than 30% of the teeth) With probing pocket depth ≥ 5mm. The age ranged between 45 and 60 years (To avoid the wide variation between individual cases in order to make the sample more homogeneous. Furthermore elderly patients above 60 years are usually not willing to have periodontal treatment). Postmenopausal status for at least 1 year. Presence of at least six teeth in the mouth. Exclusion Criteria: Any systemic disease that affect the periodontium. Women who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month. Women who use mouth washes regularly Smoking History of alcohol abuse Participation in other clinical trials. Obese women (Body mass index (BMI) ≥ 30).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega 3 group<br>scaling and root planing omega3 received 2 times daily-for 6 months | Dietary Supplement: Omega 3 fatty acids<br>* omega3 received 2 times daily-for 6 months<br>* Other names: omega 3;Procedure: scaling and root planing<br> <br> |
| Placebo Comparator: control group<br>scaling and root planing placebo soft gelatin capsules 2 times daily-for 6 months | Procedure: scaling and root planing<br> <br> Other: placebo soft gelatin capsules<br>* placebo soft gelatin capsules received 2 times daily-for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| superoxide dismutase (SOD) activity in the gingival crevicular fluid | Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 3 and 6 months post treatment. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | plaque index was recorded at baseline and at 3 and 6 months post treatment. | up to 6 months | 
| Gingival index | Gingival index was recorded at baseline, 3, 6 months post treatment | up to 6 months | 
| Probing pocket depth | Probing pocket depth in mm was recorded at baseline, 3, 6 months treatment | up to 6 months | 
| Clinical attachment level | Clinical attachment level was recorded at baseline, 3 and 6 months post treatment | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega 3 fatty acids, Root planning, chronic periodontitis