Omega-3 Polyunsaturated Fatty Acids in Non-surgical Treatment of Periodontitis

Not Applicable

Completed

• Conditions: Periodontitis; Therapeutics; Fatty Acids, Unsaturated
• Interventions: Procedure: SRP only; Dietary Supplement: fish oil

• Registration Number: NCT04477395
• Lead Sponsor: Medical University of Lodz

Brief Summary

Periodontitis is a chronic multifactorial inflammatory disease that lead to the loss of supportive tissues around the teeth with gradual deterioration of masticatory function and esthetics, resulting eventually in the decrease of the quality of life. Host immune response triggered by bacterial biofilm is responsible for the chronic periodontal inflammation and ongoing tissue loss. Polyunsaturated fatty acids (PUFAs) omega-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have anti-inflammatory properties, thus may be used for the treatment of chronic inflammatory diseases. This study is aimed to evaluate the effect of dietary supplementation with PUFAs omega-3 in the patients with periodontitis stage III and IV.

Detailed Description

Periodontitis is highly prevalent oral disease in humans affecting nearly 50% of the population worldwide. Periodontitis is multifactorial disease individually accelerated or decelerated by different factors. One of them, a bacterial biofilm, leads to dysbiosis and raise of Gram-negative bacteria.This results in the activations of immune response and clinical signs of periodontal tissue inflammation. Host modulation therapy seems to be an adequate concept for the treatment of periodontal diseases. The main assumption of this therapy is to reduce by-stander tissue destruction, to ensure rapid resolution of inflammation or even to promote regeneration of the periodontal tissues by modifying or down-regulating the destructive aspects of the host response and by up-regulating the protective or regenerative responses The goal of the present study was to assess the effect of high-dose omega-3 PUFAs EPA and DHA on the clinical outcome of non-surgical treatment of the patients with generalized periodontitis stage III and IV. It was presumed that dietary supplementation with high-dose EPA and DHA would have the potential to induce a measurable clinical outcome as a result of reduction of inflammation and minimizing tissue damage mediated by anti-inflammatory effect of omega-3 PUFAs. To address this issue, a randomized clinical trial was designed in which EPA and DHA were supplemented in adjunction to the standard periodontal therapy, scaling and root planning (SRP). Clinical outcomes of active versus control therapies were measured in addition to the quantifications of saliva cytokines, chemokines, subgingival biofilm composition and serum levels of lipids.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Primary Completion: 2021-04-10
• Study Completion: 2021-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• at least 18 scorable teeth (not including third molars),
• ≥4 teeth with PD ≥6 mm, CAL ≥5 mm,
• radiographic evidence of bone loss more than one-third of the root length,
• no periodontal treatment performed within last 6 months.

Exclusion Criteria

• smoking,
• diabetes,
• any diseases or disorders that compromise wound healing,
• chronic inflammatory disease, history of radio- or chemotherapy,
• nonsteroidal anti-inflammatory drug (NSAIDs) intake > 3 days,
• use of antibiotics or corticosteroids 3 months prior to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP alone	SRP only	Patients will receive scaling and root planing (SRP) only.
SRP plus fish oil	SRP only	Patients will receive scaling and root planing (SRP) supplemented with the dietary fish oil rich in omega-3 PUFAs: 2.6 g of EPA and 1.8 g DHA daily for 6 months.
SRP plus fish oil	fish oil	Patients will receive scaling and root planing (SRP) supplemented with the dietary fish oil rich in omega-3 PUFAs: 2.6 g of EPA and 1.8 g DHA daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Change in the percent of closed pockets	3 and 6 months	The percent of closed pockets (PD ≤ 4 mm and BOP-) at 3 and 6 months in relation to baseline

Secondary Outcome Measures

Name	Time	Method
Change in the number of sites with PD ≥ 4 mm and BOP+	3 and 6 months	Mean values of number of sites with PD ≥ 4 mm and BOP+
Change in the clinical attachment level (CAL)	3 and 6 months	Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm
Change in the probing depth (PD)	3 and 6 months	Mean values of probing depth of all sites with initial PD ≥ 4 mm
Change in the bleeding on probing (BOP)	3 and 6 months	Percent of all sites with bleeding on probing

Trial Locations

Locations (1)

Department of Periodontology and Oral Mucosal Diseases; 🇵🇱 Lodz, Poland