- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04477395
Omega-3 Polyunsaturated Fatty Acids in Non-surgical Treatment of Periodontitis
October 28, 2022 updated by: Medical University of Lodz
Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-surgical Treatment of Periodontitis: a Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lodz, Poland, 92-213
- Department of Periodontology and Oral Mucosal Diseases
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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:
Scaling and root planing will be the only method of treatment.
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Active Comparator: SRP alone
Patients will receive scaling and root planing (SRP) only.
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Scaling and root planing will be the only method of treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the percent of closed pockets
Time Frame: 3 and 6 months
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The percent of closed pockets (PD ≤ 4 mm and BOP-) at 3 and 6 months in relation to baseline
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3 and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the probing depth (PD)
Time Frame: 3 and 6 months
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Mean values of probing depth of all sites with initial PD ≥ 4 mm
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3 and 6 months
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Change in the clinical attachment level (CAL)
Time Frame: 3 and 6 months
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Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm
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3 and 6 months
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Change in the bleeding on probing (BOP)
Time Frame: 3 and 6 months
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Percent of all sites with bleeding on probing
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3 and 6 months
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Change in the number of sites with PD ≥ 4 mm and BOP+
Time Frame: 3 and 6 months
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Mean values of number of sites with PD ≥ 4 mm and BOP+
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3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natalia Lewkowicz, prof., Medical University of Lodz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
April 10, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
June 22, 2020
First Submitted That Met QC Criteria
July 15, 2020
First Posted (Actual)
July 20, 2020
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNN/251/17/KE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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