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

Primary Purpose

Periodontitis, Therapeutics, Fatty Acids, Unsaturated

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
fish oil
SRP only
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, non-surgical treatment, eicosapentaenoic acid, docosahexaenoic acid

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Periodontology and Oral Mucosal Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SRP plus fish oil

SRP alone

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the probing depth (PD)
Mean values of probing depth of all sites with initial PD ≥ 4 mm
Change in the clinical attachment level (CAL)
Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm
Change in the bleeding on probing (BOP)
Percent of all sites with bleeding on probing
Change in the number of sites with PD ≥ 4 mm and BOP+
Mean values of number of sites with PD ≥ 4 mm and BOP+

Full Information

First Posted
June 22, 2020
Last Updated
October 28, 2022
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT04477395
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Therapeutics, Fatty Acids, Unsaturated
Keywords
periodontitis, non-surgical treatment, eicosapentaenoic acid, docosahexaenoic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP plus fish oil
Arm Type
Experimental
Arm Description
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.
Arm Title
SRP alone
Arm Type
Active Comparator
Arm Description
Patients will receive scaling and root planing (SRP) only.
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil
Other Intervention Name(s)
BioMarine Medical
Intervention Description
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
Procedure
Intervention Name(s)
SRP only
Intervention Description
Scaling and root planing will be the only method of treatment.
Primary Outcome Measure Information:
Title
Change in the percent of closed pockets
Description
The percent of closed pockets (PD ≤ 4 mm and BOP-) at 3 and 6 months in relation to baseline
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Change in the probing depth (PD)
Description
Mean values of probing depth of all sites with initial PD ≥ 4 mm
Time Frame
3 and 6 months
Title
Change in the clinical attachment level (CAL)
Description
Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm
Time Frame
3 and 6 months
Title
Change in the bleeding on probing (BOP)
Description
Percent of all sites with bleeding on probing
Time Frame
3 and 6 months
Title
Change in the number of sites with PD ≥ 4 mm and BOP+
Description
Mean values of number of sites with PD ≥ 4 mm and BOP+
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Lewkowicz, Prof.
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology and Oral Mucosal Diseases
City
Lodz
ZIP/Postal Code
92-213
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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