The Effects of DHA on Periodontitis (DAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01976806|
Recruitment Status : Completed
First Posted : November 6, 2013
Results First Posted : March 24, 2014
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis Gingivitis Inflammation||Drug: Aspirin Drug: Docosahexaenoic acid Drug: Placebo (for Docosahexaenoic acid)||Phase 2|
- 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.
- 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.
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial|
|Study Start Date :||June 2009|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Experimental: 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
Other Names:Drug: Docosahexaenoic acid
Other Name: DHA
Active Comparator: Aspirin & Placebo
Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Other Names:Drug: Placebo (for Docosahexaenoic acid)
Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
Other Name: 50% corn oil/50% soybean oil
- Change in Pocket Depth (mm) [ Time Frame: Baseline and 3 months ]Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).
- Change in Gingival Index (0-3) [ Time Frame: Baseline and 3 months ]
Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).
0: No inflammation.
- Mild inflammation, slight change in color, slight edema, no bleeding on probing.
- Moderate inflammation, moderate glazing, redness, bleeding on probing.
- Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
- Change in Plaque Index (0-3) [ Time Frame: Baseline and 3 months ]
Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.
0: No plaque
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.
- Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
- Sites With Bleeding on Probing (Yes/no) [ Time Frame: 3 months ]Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.
- Gingival Crevicular Fluid High Sensitivity C-reactive Protein [ Time Frame: Baseline and 3 months ]Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.
- Gingival Crevicular Fluid Interleukin-6 [ Time Frame: Baseline and 3 months ]Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.
- Gingival Crevicular Fluid Interleukin-1 Beta [ Time Frame: Baseline and 3 months ]Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.
- Serum High-sensitivity C-reactive Protein [ Time Frame: Baseline and 3 months ]Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.
- Serum High-sensitivity Interleukin-6 [ Time Frame: Baseline and 3 months ]Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.
- Serum Soluble Vascular Cell Adhesion Molecule [ Time Frame: Baseline and 3 months ]Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.
- Urine N-Terminal Telopeptides [ Time Frame: Baseline and 3 months ]Urine N-Terminal Telopeptides are a measure of systemic bone turnover.
- Change in Red Blood Cell Membrane Docosahexaenoic Acid [ Time Frame: Baseline and 3 months ]Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976806
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Asghar Z Naqvi, MD, MPH, MNS||Beth Israel Deaconess Medical Center; Harvard Medical School|
|Study Chair:||Kenneth J Mukamal, MD, MPH, MA||Beth Israel Deaconess Medical Center|