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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR025758-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| Harvard Medical School (HMS and HSDM) | OTHER |
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The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin & Docosahexaenoic acid | Experimental | 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 & Placebo | Active Comparator | Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pocket Depth (mm) | 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). | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Index (0-3) | Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3). Score Criteria: 0: No inflammation.
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Red Blood Cell Membrane Docosahexaenoic Acid | Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence. | Baseline and 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asghar Z Naqvi, MD, MPH, MNS | Beth Israel Deaconess Medical Center; Harvard Medical School | Principal Investigator |
| Kenneth J Mukamal, MD, MPH, MA | Beth Israel Deaconess Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28517974 | Background | 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. | |
| 24970858 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all subjects that completed follow-up
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Aspirin & Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pocket Depth (mm) | 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). | Posted | Mean | Standard Error | mm | Baseline and 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Mukamal | Beth Israel Deaconess Medical Center | 617-754-1401 | kmukamal@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Docosahexaenoic acid | Drug |
|
|
| Placebo (for Docosahexaenoic acid) | Drug | Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules |
|
|
| Baseline and 3 months |
| Change in Plaque Index (0-3) | Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line. Score Criteria: 0: No plaque
| Baseline and 3 months |
| Sites With Bleeding on Probing (Yes/no) | 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. | 3 months |
| Gingival Crevicular Fluid High Sensitivity C-reactive Protein | 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. | Baseline and 3 months |
| Gingival Crevicular Fluid Interleukin-6 | Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation. | Baseline and 3 months |
| Gingival Crevicular Fluid Interleukin-1 Beta | Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation. | Baseline and 3 months |
| Serum High-sensitivity C-reactive Protein | Serum high-sensitivity C-reactive protein is a measure of systemic inflammation. | Baseline and 3 months |
| Serum High-sensitivity Interleukin-6 | Serum high-sensitivity interleukin-6 is a measure of systemic inflammation. | Baseline and 3 months |
| Serum Soluble Vascular Cell Adhesion Molecule | Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation. | Baseline and 3 months |
| Urine N-Terminal Telopeptides | Urine N-Terminal Telopeptides are a measure of systemic bone turnover. | Baseline and 3 months |
| Withdrawal by Subject |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoking Status | Number | participants |
|
| BMI (kg/m2) | Number | participants |
|
| Hypertension | Number | participants |
|
| Hyperlipidemia | Number | participants |
|
|
|
|
| Secondary | Change in Gingival Index (0-3) | Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3). Score Criteria: 0: No inflammation.
| Posted | Mean | Standard Error | GI units | Baseline and 3 months |
|
|
|
| Secondary | Change in Plaque Index (0-3) | Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line. Score Criteria: 0: No plaque
| Posted | Mean | Standard Error | Plaque index units | Baseline and 3 months |
|
|
|
| Secondary | Sites With Bleeding on Probing (Yes/no) | 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. | Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript. | Posted | Count of Units | Sites | 3 months | Sites | Sites |
|
|
|
| Secondary | Gingival Crevicular Fluid High Sensitivity C-reactive Protein | 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. | Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected. | Posted | Mean | Standard Error | ng/mL | Baseline and 3 months |
|
|
|
| Secondary | Gingival Crevicular Fluid Interleukin-6 | Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation. | Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected. | Posted | Mean | Standard Error | pg/mL | Baseline and 3 months |
|
|
|
| Secondary | Gingival Crevicular Fluid Interleukin-1 Beta | Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation. | Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected. | Posted | Mean | Standard Error | pg/mL | Baseline and 3 months |
|
|
|
| Secondary | Serum High-sensitivity C-reactive Protein | Serum high-sensitivity C-reactive protein is a measure of systemic inflammation. | Posted | Mean | Standard Error | mg/L | Baseline and 3 months |
|
|
|
| Secondary | Serum High-sensitivity Interleukin-6 | Serum high-sensitivity interleukin-6 is a measure of systemic inflammation. | Posted | Mean | Standard Error | pg/mL | Baseline and 3 months |
|
|
|
| Secondary | Serum Soluble Vascular Cell Adhesion Molecule | Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation. | Posted | Mean | Standard Error | ng/mL | Baseline and 3 months |
|
|
|
| Secondary | Urine N-Terminal Telopeptides | Urine N-Terminal Telopeptides are a measure of systemic bone turnover. | Posted | Mean | Standard Error | nM BCE | Baseline and 3 months |
|
|
|
| Other Pre-specified | Change in Red Blood Cell Membrane Docosahexaenoic Acid | Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence. | Posted | Mean | Standard Error | % of total RBC FA | Baseline and 3 months |
|
|
|
| 0 |
| 27 |
| 7 |
| 27 |
| EG001 | Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) | 0 | 28 | 8 | 28 |
| Gingival bleeding while flossing | Blood and lymphatic system disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Melena | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Cavity | Infections and infestations | Systematic Assessment |
|
| Verbally abusive toward staff | Psychiatric disorders | Systematic Assessment |
|
| Chipped tooth | General disorders | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | Systematic Assessment |
|
| Intermittent palpitations | Cardiac disorders | Systematic Assessment |
|
| Diaphoresis | General disorders | Systematic Assessment |
|
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| D005882 |
| Gingival Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |