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

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ClinicalTrials.gov Identifier: NCT02719587
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
İlker KESKINER, Ondokuz Mayıs University

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Placebo Procedure: Omega-3 Procedure: SRP Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
Procedure: Placebo
placebo drug identical except for the fish oil supplement, were only performed at baseline.

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

Active Comparator: 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.
Procedure: Omega-3
omega-3 PUFAs supplement, were only performed at baseline.

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




Primary Outcome Measures :
  1. change in levels of salivary TNF alpha [ Time Frame: From baseline to 1, 3, 6 months ]

Secondary Outcome Measures :
  1. change in levels of salivary SOD [ Time Frame: From baseline to 1, 3, 6 months ]


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: İlker KESKINER, Assist.Prof.Dr., Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT02719587     History of Changes
Other Study ID Numbers: 1491-831-09/1539
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by İlker KESKINER, Ondokuz Mayıs University:
saliva
omega-3
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases