NCT04477395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3.4 years

First QC Date

June 22, 2020

Last Update Submit

October 28, 2022

Conditions

PeriodontitisTherapeuticsFatty Acids, Unsaturated

Keywords

periodontitisnon-surgical treatmenteicosapentaenoic aciddocosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in the probing depth (PD)

    3 and 6 months

  • Change in the clinical attachment level (CAL)

    3 and 6 months

  • Change in the bleeding on probing (BOP)

    3 and 6 months

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

    3 and 6 months

Study Arms (2)

SRP plus fish oil

EXPERIMENTAL

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.

Dietary Supplement: fish oilProcedure: SRP only

SRP alone

ACTIVE COMPARATOR

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

Procedure: SRP only

Interventions

fish oilDIETARY_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.

Also known as: BioMarine Medical
SRP plus fish oil
SRP onlyPROCEDURE

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

SRP aloneSRP plus fish oil

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology and Oral Mucosal Diseases

Lodz, 92-213, Poland

Location

Related Publications (1)

  • Stando-Retecka M, Piatek P, Namiecinska M, Bonikowski R, Lewkowicz P, Lewkowicz N. Clinical and microbiological outcomes of subgingival instrumentation supplemented with high-dose omega-3 polyunsaturated fatty acids in periodontal treatment - a randomized clinical trial. BMC Oral Health. 2023 May 13;23(1):290. doi: 10.1186/s12903-023-03018-7.

    PMID: 37179297DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Natalia Lewkowicz, Prof.

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 20, 2020

Study Start

November 1, 2017

Primary Completion

April 10, 2021

Study Completion

September 30, 2021

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

PL(1)