Chronic PeriodontitisEarly Phase 1NCT02719587
Dietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
A Early Phase 1 study testing Omega-3 and SRP in people with Chronic Periodontitis, run by İlker KESKINER.
Trial summary
The investigators primary objective in this clinical intervention study, therefore, was to explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary markers (in patients with chronic periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Omega-3 and SRP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jan 2010
- Phase
- Early Phase 1
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed with chronic periodontitis
- had at least nine posterior teeth (not including third molars and teeth with bridges and crowns)
- with 5-7 mm pocket depth
- three teeth with 6 mm or more of probing attachment loss enrolled in the study
Who cannot join
- patients were excluded on the basis of periodontal surgery within the last year;
- SRP as part of initial periodontal therapy within the past 6 months;
- history of diabetes, any diseases or disorders that compromise wound healing, any history of acute or chronic inflammatory disease,
- any oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, and oral cancer) and use of aspirin
- other non-steroidal anti-inflammatory drugs or antibiotics within the last 6 months.
About this study
Official title: Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
The investigators primary objective in this clinical intervention study, therefore, was to explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary markers (in patients with chronic periodontitis.
Read the detailed description
Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly allocated into two groups. The control group (n=15) was treated with scaling and root planing (SRP)+placebo whereas the test group (n=15) was treated with SRP and dietary supplementation of low-dose omega-3 PUFAs (6.25 mg EPA and 19.19 mg DHA). Clinical parameters were taken at baseline, 1, 3 and 6 months following therapy. Saliva samples were obtained at the same time intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD).
- Conditions
- Chronic Periodontitis
- Being tested
- Placebo, Omega-3, SRP
- Keywords
- saliva, omega-3
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboProcedure or surgery
placebo drug identical except for the fish oil supplement, were only performed at baseline.
Omega-3Procedure or surgery
omega-3 PUFAs supplement, were only performed at baseline.
SRPProcedure or surgery
Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Control group (8 males, 7 females; 42.54±5.82 years) (SRP): SRP followed by administration of a placebo. The placebo was identical except for the fish oil. Receives: Procedure: Placebo; Procedure: SRP |
| test group | Active comparator | Test group (8 males, 7 females; 40.87±9.7 years) (SRP+omega-3 PUFAs): SRP followed by omega-3 PUFAs supplementation. The test drug contained omega-3 PUFAs including 6.25 mg EPA and 19.19 mg DHA obtained from the Atlantic salmon Salmo salar.Both test and placebo drugs were taken twice a day by the patients for six months. Subjects came to the clinic every 4 weeks during the 6 month course of the experiment to replenish their medication. Remaining medications were checked for compliance. At each evaluation visit (1, 3 and 6 months), oral soft and hard tissue examinations and adverse-event evaluations were performed. Receives: Procedure: Omega-3; Procedure: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in levels of salivary TNF alpha
Measured: From baseline to 1, 3, 6 months
Secondary outcomes (1)
change in levels of salivary SOD
Measured: From baseline to 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionJan 2010
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 Chronic 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlker KESKINER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İlker KESKINER, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719587
- Sponsor's protocol ID
- 1491-831-09/1539
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Keskiner I, Saygun I, Bal V, Serdar M, Kantarci A. Dietary supplementation with low-dose omega-3 fatty acids reduces salivary tumor necrosis factor-alpha levels in patients with chronic periodontitis: a randomized controlled clinical study. J Periodontal Res. 2017 Aug;52(4):695-703. doi: 10.1111/jre.12434. Epub 2017 Feb 8.
PubMed 28177133
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT02719587
- Acronym / sponsor ID
- 1491-831-09/1539
- Conditions
- Chronic Periodontitis
- Keywords
- saliva, omega-3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- İlker KESKINERUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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.
The investigators primary objective in this clinical intervention study, therefore, was to explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary markers (in patients with chronic periodontitis.
Detailed description
Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly allocated into two groups. The control group (n=15) was treated with scaling and root planing (SRP)+placebo whereas the test group (n=15) was treated with SRP and dietary supplementation of low-dose omega-3 PUFAs (6.25 mg EPA and 19.19 mg DHA). Clinical parameters were taken at baseline, 1, 3 and 6 months following therapy. Saliva samples were obtained at the same time intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: Placebo, Procedure: SRPControl group (8 males, 7 females; 42.54±5.82 years) (SRP): SRP followed by administration of a placebo. The placebo was identical except for the fish oil. |
| test group | Active comparator | Procedure: Omega-3, Procedure: SRPTest group (8 males, 7 females; 40.87±9.7 years) (SRP+omega-3 PUFAs): SRP followed by omega-3 PUFAs supplementation. The test drug contained omega-3 PUFAs including 6.25 mg EPA and 19.19 mg DHA obtained from the Atlantic salmon Salmo salar.Both test and placebo drugs were taken twice a day by the patients for six months. Subjects came to the clinic every 4 weeks during the 6 month course of the experiment to replenish their medication. Remaining medications were checked for compliance. At each evaluation visit (1, 3 and 6 months), oral soft and hard tissue examinations and adverse-event evaluations were performed. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients diagnosed with chronic periodontitis
- had at least nine posterior teeth (not including third molars and teeth with bridges and crowns)
- with 5-7 mm pocket depth
- three teeth with 6 mm or more of probing attachment loss enrolled in the study
Key exclusion criteria (5 listed)
- patients were excluded on the basis of periodontal surgery within the last year;
- SRP as part of initial periodontal therapy within the past 6 months;
- history of diabetes, any diseases or disorders that compromise wound healing, any history of acute or chronic inflammatory disease,
- any oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, and oral cancer) and use of aspirin
- other non-steroidal anti-inflammatory drugs or antibiotics within the last 6 months.
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 |
|---|---|---|
| Placeboplacebo drug identical except for the fish oil supplement, were only performed at baseline. | Procedure or surgery | control group |
| Omega-3omega-3 PUFAs supplement, were only performed at baseline. | Procedure or surgery | test group |
| SRPInstrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement. | Procedure or surgery | control group, test group |
Primary outcome
change in levels of salivary TNF alpha
Time frame: From baseline to 1, 3, 6 months
1 secondary outcome
change in levels of salivary SOD
Time frame: From baseline to 1, 3, 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 25 Mar 2016.
- Derived from this study: PubMed 28177133Keskiner I, Saygun I, Bal V, Serdar M, Kantarci A. Dietary supplementation with low-dose omega-3 fatty acids reduces salivary tumor necrosis factor-alpha levels in patients with chronic periodontitis: a randomized controlled clinical study. J Periodontal Res. 2017 Aug;52(4):695-703. doi: 10.1111/jre.12434. Epub 2017 Feb 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omega-3 and SRP in people with Chronic Periodontitis, run by İlker KESKINER.
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 5 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 levels of salivary TNF alpha (time frame: From baseline to 1, 3, 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 NCT02719587, 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 25 Mar 2016.