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

NCT02719587 | Completed Early Phase 1 DMC

• 1 other identifier: 1491-831-09/1539
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Keywords

saliva; omega-3

Outcome Measures

Primary Outcomes (1)

• change in levels of salivary TNF alpha

  From baseline to 1, 3, 6 months

Secondary Outcomes (1)

• change in levels of salivary SOD

  From baseline to 1, 3, 6 months

Study Arms (2)

control group

PLACEBO COMPARATOR

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; Procedure: SRP

test group

ACTIVE COMPARATOR

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; Procedure: SRP

Interventions

Placebo PROCEDURE

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

control group

Omega-3 PROCEDURE

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

test group

SRP PROCEDURE

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

control group; test group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• İlker KESKINER: lead

Related Publications (1)

• 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.

  PMID: 28177133 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist.Prof.Dr.

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 25, 2016
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share