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NCT Number: NCT04477395

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral Mucosal Diseases

Lodz, 92-213, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Fish Oil

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.

Other names: BioMarine Medical

SRP only

Procedure

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

Primary outcomes

  1. Change in the percent of closed pockets

    Time frame: 3 and 6 months

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

Secondary outcomes

  1. Change in the probing depth (PD)

    Time frame: 3 and 6 months

    Mean values of probing depth of all sites with initial PD ≥ 4 mm

  2. Change in the clinical attachment level (CAL)

    Time frame: 3 and 6 months

    Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm

  3. Change in the bleeding on probing (BOP)

    Time frame: 3 and 6 months

    Percent of all sites with bleeding on probing

  4. Change in the number of sites with PD ≥ 4 mm and BOP+

    Time frame: 3 and 6 months

    Mean values of number of sites with PD ≥ 4 mm and BOP+

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-surgical Treatment of Periodontitis: a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Nov 1, 2022

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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