Dietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis

Study Overview
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Brief Summary
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The investigators primary objective in this clinical intervention study, therefore, was to explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary markers (in patients with chronic periodontitis.

Detailed Description
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Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly allocated into two groups. The control group (n=15) was treated with scaling and root planing (SRP)+placebo whereas the test group (n=15) was treated with SRP and dietary supplementation of low-dose omega-3 PUFAs (6.25 mg EPA and 19.19 mg DHA). Clinical parameters were taken at baseline, 1, 3 and 6 months following therapy. Saliva samples were obtained at the same time intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD).

Official Title
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Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Placebo
* Procedure: Omega-3
* Procedure: SRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with chronic periodontitis had at least nine posterior teeth (not including third molars and teeth with bridges and crowns) with 5-7 mm pocket depth three teeth with 6 mm or more of probing attachment loss enrolled in the study Exclusion Criteria: patients were excluded on the basis of periodontal surgery within the last year; SRP as part of initial periodontal therapy within the past 6 months; history of diabetes, any diseases or disorders that compromise wound healing, any history of acute or chronic inflammatory disease, any oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, and oral cancer) and use of aspirin other non-steroidal anti-inflammatory drugs or antibiotics within the last 6 months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Placebo Comparator: control group<br>Control group (8 males, 7 females; 42.54±5.82 years) (SRP): SRP followed by administration of a placebo. The placebo was identical except for the fish oil. | Procedure: Placebo<br>* placebo drug identical except for the fish oil supplement, were only performed at baseline.<br>Procedure: SRP<br>* Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.<br>|
| Active Comparator: test group<br>Test group (8 males, 7 females; 40.87±9.7 years) (SRP+omega-3 PUFAs): SRP followed by omega-3 PUFAs supplementation. The test drug contained omega-3 PUFAs including 6.25 mg EPA and 19.19 mg DHA obtained from the Atlantic salmon Salmo salar.Both test and placebo drugs were taken twice a day by the patients for six months. Subjects came to the clinic every 4 weeks during the 6 month course of the experiment to replenish their medication. Remaining medications were checked for compliance. At each evaluation visit (1, 3 and 6 months), oral soft and hard tissue examinations and adverse-event evaluations were performed. | Procedure: Omega-3<br>* omega-3 PUFAs supplement, were only performed at baseline.<br>Procedure: SRP<br>* Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in levels of salivary TNF alpha |  | From baseline to 1, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in levels of salivary SOD |  | From baseline to 1, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saliva, omega-3