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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477395
• Other study ID #: RNN/251/17/KE
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2022
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Acids, Unsaturated
• Periodontitis
• Therapeutics

Intervention

Dietary Supplement:
• 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.

Procedure:
• SRP only
Scaling and root planing will be the only method of treatment.

Locations

Country	Name	City	State
Poland	Department of Periodontology and Oral Mucosal Diseases	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the percent of closed pockets	The percent of closed pockets (PD = 4 mm and BOP-) at 3 and 6 months in relation to baseline	3 and 6 months
Secondary	Change in the probing depth (PD)	Mean values of probing depth of all sites with initial PD = 4 mm	3 and 6 months
Secondary	Change in the clinical attachment level (CAL)	Mean values of clinical attachment level of all sites with initial PD = 4 mm	3 and 6 months
Secondary	Change in the bleeding on probing (BOP)	Percent of all sites with bleeding on probing	3 and 6 months
Secondary	Change in the number of sites with PD = 4 mm and BOP+	Mean values of number of sites with PD = 4 mm and BOP+	3 and 6 months