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Completed

NCT Number: NCT02719587

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Procedure

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

Omega-3

Procedure

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

SRP

Procedure

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

Primary outcomes

  1. change in levels of salivary TNF alpha

    Time frame: From baseline to 1, 3, 6 months

Secondary outcomes

  1. change in levels of salivary SOD

    Time frame: From baseline to 1, 3, 6 months

Sponsors and collaborators

Lead sponsor

İlker KESKINER

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 25, 2016
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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