Clinical trial NCT04477395: Omega-3 Polyunsaturated Fatty Acids in Non-surgical Treatment of Periodontitis
Official title: Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-surgical Treatment of Periodontitis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Therapeutics
Fatty Acids, Unsaturated
Keywords: periodontitis
non-surgical treatment
eicosapentaenoic acid
docosahexaenoic acid
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the percent of closed pockets
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Change in the probing depth (PD)
timeFrame: 3 and 6 months
measure: Change in the clinical attachment level (CAL)
timeFrame: 3 and 6 months
measure: Change in the bleeding on probing (BOP)
timeFrame: 3 and 6 months
measure: Change in the number of sites with PD ≥ 4 mm and BOP+
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Periodontology and Oral Mucosal Diseases
Study officials:
affiliation: Medical University of Lodz
name: Natalia Lewkowicz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: