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

Early Phase 1

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: Placebo; Procedure: Omega-3; Procedure: SRP

• Registration Number: NCT02719587
• Lead Sponsor: İlker KESKINER

Brief Summary

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

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).

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Study First Posted: 2016-03-25
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	SRP	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.
control group	Placebo	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.
test group	Omega-3	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.
test group	SRP	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.

Primary Outcome Measures

Name	Time	Method
change in levels of salivary TNF alpha	From baseline to 1, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
change in levels of salivary SOD	From baseline to 1, 3, 6 months