Ignite Creation Date:
2024-05-06 @ 2:08 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01976806
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2013-10-30
Brief Title:
The Effects of DHA on Periodontitis
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
The Effects of Docosahexaenoic Acid on Periodontitis in Adults A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAP
Brief Summary:
The purpose of this study is to determine whether docosahexaenoic acid DHA is effective in the treatment of periodontitis in adults
Detailed Description:
1 The primary aim of this study is to investigate the effect of docosahexaenoic acid DHA 2 gmday plus low dose aspirin ASA 81 mgdaycompared 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 yesno 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR025758-02 | NIH | None | httpsreporternihgovquickSearchUL1RR025758-02 |