PeriodontitisNCT04477395
Omega-3 Polyunsaturated Fatty Acids in Non-surgical Treatment of Periodontitis
A study testing fish oil and SRP only in people with Periodontitis and Therapeutics, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontitis, Therapeutics, Fatty Acids, Unsaturated
- What is being tested?
- fish oil and SRP only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Periodontology and Oral Mucosal Diseases
Lodz, 92-213
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Therapeutics, Fatty Acids, Unsaturated
- Being tested
- fish oil, SRP only
- Keywords
- periodontitis, non-surgical treatment, eicosapentaenoic acid, docosahexaenoic acid
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
Also called BioMarine Medical
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.
SRP onlyProcedure or surgery
Scaling and root planing will be the only method of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: fish oil; Procedure: SRP only |
| SRP alone | Active comparator | Patients will receive scaling and root planing (SRP) only. Receives: Procedure: SRP only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 and 6 months
Secondary outcomes (4)
Change in the probing depth (PD)
Mean values of probing depth of all sites with initial PD ≥ 4 mm
Measured: 3 and 6 months
Change in the clinical attachment level (CAL)
Mean values of clinical attachment level of all sites with initial PD ≥ 4 mm
Measured: 3 and 6 months
Change in the bleeding on probing (BOP)
Percent of all sites with bleeding on probing
Measured: 3 and 6 months
Change in the number of sites with PD ≥ 4 mm and BOP+
Mean values of number of sites with PD ≥ 4 mm and BOP+
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Nov 2017
- Primary completion10 Apr 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Lewkowicz, Prof., Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477395
- Sponsor's protocol ID
- RNN/251/17/KE
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37179297
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Polyunsaturated Fatty Acids EPA and DHA as an Adjunct to Non-surgical Treatment of Periodontitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04477395
- Acronym / sponsor ID
- RNN/251/17/KE
- Conditions
- Periodontitis, Therapeutics, Fatty Acids, Unsaturated
- Keywords
- periodontitis, non-surgical treatment, eicosapentaenoic acid, docosahexaenoic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP plus fish oil | Experimental | Dietary Supplement: fish oil, Procedure: SRP onlyPatients 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. |
| SRP alone | Active comparator | Procedure: SRP onlyPatients will receive scaling and root planing (SRP) only. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish oilAlso: BioMarine MedicalSRP 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. | Dietary supplement | SRP plus fish oil |
| SRP onlyScaling and root planing will be the only method of treatment. | Procedure or surgery | SRP alone, SRP plus fish oil |
Primary outcome
Change in the percent of closed pockets
Time frame: 3 and 6 months
The percent of closed pockets (PD ≤ 4 mm and BOP-) at 3 and 6 months in relation to baseline
4 secondary outcomes
Change in the probing depth (PD)
Time frame: 3 and 6 months
Change in the clinical attachment level (CAL)
Time frame: 3 and 6 months
Change in the bleeding on probing (BOP)
Time frame: 3 and 6 months
Change in the number of sites with PD ≥ 4 mm and BOP+
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 37179297Stando-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Lewkowicz, Prof. principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil and SRP only in people with Periodontitis and Therapeutics, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percent of closed pockets (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.