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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719587
• Other study ID #: 1491-831-09/1539
• Status: Completed
• Phase: Phase 0
• First received: March 6, 2016
• Last updated: March 24, 2016
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2016
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Placebo
placebo drug identical except for the fish oil supplement, were only performed at baseline.
• Omega-3
omega-3 PUFAs supplement, were only performed at baseline.
• SRP
Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ilker KESKINER

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in levels of salivary TNF alpha		From baseline to 1, 3, 6 months	No
Secondary	change in levels of salivary SOD		From baseline to 1, 3, 6 months	No