Back to resultsDietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Omega-3
SRP
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring saliva, omega-3
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control group
test group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
change in levels of salivary TNF alpha
Secondary Outcome Measures
change in levels of salivary SOD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02719587
Brief Title
Dietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Official Title
Dietary Supplementation With Low-Dose Omega-3 Fatty Acids Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
İlker KESKINER
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
saliva, omega-3
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
test group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
placebo drug identical except for the fish oil supplement, were only performed at baseline.
Intervention Type
Procedure
Intervention Name(s)
Omega-3
Intervention Description
omega-3 PUFAs supplement, were only performed at baseline.
Intervention Type
Procedure
Intervention Name(s)
SRP
Intervention Description
Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.
Primary Outcome Measure Information:
Title
change in levels of salivary TNF alpha
Time Frame
From baseline to 1, 3, 6 months
Secondary Outcome Measure Information:
Title
change in levels of salivary SOD
Time Frame
From baseline to 1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28177133
Citation
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.
Results Reference
derived
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Dietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
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