Inflammation Clinical Trial
Official title:
The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.
1. The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA;
2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis
over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as
measured by objective periodontal exam, including decreased pocket depth (mm), gingival
index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to ASA alone.
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.
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