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

NCT ID: NCT04477395

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-09-30

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.

Conditions

Periodontitis; Therapeutics; Fatty Acids, Unsaturated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SRP plus 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.

Group Type: EXPERIMENTAL

fish oil

Intervention Type: DIETARY_SUPPLEMENT

SRP will be supplemented with the dietary fish oil rich in omega-3 PUFAs EPA and DHA for 6 months. Fish oil (BioMarine Medical, 200 ml liquid), obtained from Tasmanian deep sea shark and Norwegian cod liver and sardine, anchovy and mackerel muscle, will be administered two times a day at a dose 10 ml. Daily dose of 20 ml provides 2.6 g of EPA and 1.8 g of DHA.

SRP only

Intervention Type: PROCEDURE

Scaling and root planing will be the only method of treatment.

SRP alone

Patients will receive scaling and root planing (SRP) only.

Group Type: ACTIVE_COMPARATOR

SRP only

Intervention Type: PROCEDURE

Scaling and root planing will be the only method of treatment.

Interventions

fish oil

SRP will be supplemented with the dietary fish oil rich in omega-3 PUFAs EPA and DHA for 6 months. Fish oil (BioMarine Medical, 200 ml liquid), obtained from Tasmanian deep sea shark and Norwegian cod liver and sardine, anchovy and mackerel muscle, will be administered two times a day at a dose 10 ml. Daily dose of 20 ml provides 2.6 g of EPA and 1.8 g of DHA.

Intervention Type: DIETARY_SUPPLEMENT

SRP only

Scaling and root planing will be the only method of treatment.

Intervention Type: PROCEDURE

Other Intervention Names

BioMarine Medical

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Lewkowicz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz

Locations

Department of Periodontology and Oral Mucosal Diseases

Lodz, , Poland

Countries

Poland

References

Stando-Retecka M, Piatek P, Namiecinska M, Bonikowski R, Lewkowicz P, Lewkowicz N. Clinical and microbiological outcomes of subgingival instrumentation supplemented with high-dose omega-3 polyunsaturated fatty acids in periodontal treatment - a randomized clinical trial. BMC Oral Health. 2023 May 13;23(1):290. doi: 10.1186/s12903-023-03018-7.

Reference Type: DERIVED

PMID: 37179297 (View on PubMed)

Other Identifiers

RNN/251/17/KE

Identifier Type: -

Identifier Source: org_study_id