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

NCT ID: NCT02719587

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-01-31

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).

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

placebo drug identical except for the fish oil supplement, were only performed at baseline.

SRP

Intervention Type: PROCEDURE

Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.

test group

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.

Group Type: ACTIVE_COMPARATOR

Omega-3

Intervention Type: PROCEDURE

omega-3 PUFAs supplement, were only performed at baseline.

SRP

Intervention Type: PROCEDURE

Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.

Interventions

Placebo

placebo drug identical except for the fish oil supplement, were only performed at baseline.

Intervention Type: PROCEDURE

Omega-3

omega-3 PUFAs supplement, were only performed at baseline.

Intervention Type: PROCEDURE

SRP

Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

İlker KESKINER

OTHER

Sponsor Role: lead

Responsible Party

İlker KESKINER

Assist.Prof.Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

References

Keskiner I, Saygun I, Bal V, Serdar M, Kantarci A. Dietary supplementation with low-dose omega-3 fatty acids reduces salivary tumor necrosis factor-alpha levels in patients with chronic periodontitis: a randomized controlled clinical study. J Periodontal Res. 2017 Aug;52(4):695-703. doi: 10.1111/jre.12434. Epub 2017 Feb 8.

Reference Type: DERIVED

PMID: 28177133 (View on PubMed)

Other Identifiers

1491-831-09/1539

Identifier Type: -

Identifier Source: org_study_id