Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2009-06-30
2011-09-30
Brief Summary
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Detailed Description
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2. Assess the effect of DHA and ASA exposure on markers of local inflammation, including gingival crevicular fluid (GCF) CRP, IL-1 beta and IL-6 three months after exposure to DHA plus ASA compared to ASA alone.
3. Evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to DHA and ASA compared to ASA alone. Our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state.
4. Assess the effect of DHA and ASA exposure on markers of systemic inflammation, including serum C-Reactive Protein (CRP), interleukin-6 (IL-6) and vascular adhesion molecule (VCAM) compared to ASA. Our hypothesis is that there will be a decrease in serum CRP, IL-6 and VCAM three months after exposure to DHA plus ASA compared to ASA alone.
5. Assess the effect of DHA and ASA exposure on markers of systemic bone turnover, including urine N-terminal telopeptide (NTx) compared to ASA. Our hypothesis is that there will be a decrease in urine NTx three months after exposure to DHA plus ASA compared to ASA alone.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aspirin & Docosahexaenoic acid
Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
Aspirin
Docosahexaenoic acid
Aspirin & Placebo
Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Aspirin
Placebo (for Docosahexaenoic acid)
Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
Interventions
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Aspirin
Docosahexaenoic acid
Placebo (for Docosahexaenoic acid)
Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>20 natural teeth (excluding third molars)
* no orthodontic appliances
* periodontitis defined as \>4 teeth with pocket probing depths \>5 mm
Exclusion Criteria
* diabetes
* severe chronic diseases
* gastrointestinal bleeding
* uncontrolled chronic diseases
* autoimmune disorders
* conditions requiring antibiotic prophylaxis
* warfarin
* clopidogrel
* antimicrobial therapy within 30 days
* chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)
* omega-3 fatty acid use within 6 months
* loose teeth
* painful teeth
* periodontal abscess
* pocket depths \>10 mm in \>1 tooth
* periodontal therapy within the past two years
* allergy to aspirin
* allergy to fish oil
* allergy to corn oil
* allergy to soybean oil
40 Years
ALL
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
Harvard Medical School (HMS and HSDM)
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Kenneth Mukamal
Associate Professor of Medicine
Principal Investigators
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Asghar Z Naqvi, MD, MPH, MNS
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center; Harvard Medical School
Kenneth J Mukamal, MD, MPH, MA
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Naqvi AZ, Mu L, Hasturk H, Van Dyke TE, Mukamal KJ, Goodson JM. Impact of Docosahexaenoic Acid Therapy on Subgingival Plaque Microbiota. J Periodontol. 2017 Sep;88(9):887-895. doi: 10.1902/jop.2017.160398. Epub 2017 May 18.
Naqvi AZ, Hasturk H, Mu L, Phillips RS, Davis RB, Halem S, Campos H, Goodson JM, Van Dyke TE, Mukamal KJ. Docosahexaenoic Acid and Periodontitis in Adults: A Randomized Controlled Trial. J Dent Res. 2014 Aug;93(8):767-73. doi: 10.1177/0022034514541125. Epub 2014 Jun 26.
Other Identifiers
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GM-023
Identifier Type: -
Identifier Source: org_study_id