Trial Outcomes & Findings for The Effects of DHA on Periodontitis (NCT NCT01976806)
NCT ID: NCT01976806
Last Updated: 2017-12-13
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
The Effects of DHA on Periodontitis
Baseline characteristics by cohort
| Measure |
Aspirin & Docosahexaenoic Acid
n=24 Participants
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
n=22 Participants
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
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 8 • n=93 Participants
|
57 years
STANDARD_DEVIATION 8 • n=4 Participants
|
55 years
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Smoking Status
Current
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Smoking Status
Former
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Smoking Status
Never
|
16 participants
n=93 Participants
|
15 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
BMI (kg/m2)
Normal (18.5-24.9 kg/m2)
|
9 participants
n=93 Participants
|
5 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
BMI (kg/m2)
Overweight (25-30 kg/m2)
|
4 participants
n=93 Participants
|
10 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
BMI (kg/m2)
Obese (>30 kg/m2)
|
11 participants
n=93 Participants
|
7 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Hypertension
Hypertension
|
4 participants
n=93 Participants
|
6 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Hypertension
No Hypertension
|
20 participants
n=93 Participants
|
16 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Hyperlipidemia
Hyperlipidemia
|
5 participants
n=93 Participants
|
4 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Hyperlipidemia
No Hyperlipidemia
|
19 participants
n=93 Participants
|
18 participants
n=4 Participants
|
37 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPocket 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).
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=24 Participants
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
n=22 Participants
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
|
|---|---|---|
|
Change in Pocket Depth (mm)
|
-0.71 mm
Standard Error 0.07
|
-0.54 mm
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsGingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3). Score Criteria: 0: No inflammation. 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=24 Participants
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
n=22 Participants
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
|
|---|---|---|
|
Change in Gingival Index (0-3)
|
-0.26 GI units
Standard Error 0.04
|
-0.07 GI units
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPlaque 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 1. 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. 2. 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. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=24 Participants
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
n=22 Participants
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
|
|---|---|---|
|
Change in Plaque Index (0-3)
|
-0.10 Plaque index units
Standard Error 0.06
|
0.07 Plaque index units
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript.
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.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=271 Sites
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
n=261 Sites
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
|
|---|---|---|
|
Sites With Bleeding on Probing (Yes/no)
|
202 Sites
|
227 Sites
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.
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.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=20 Participants
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
n=19 Participants
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
|
|---|---|---|
|
Gingival Crevicular Fluid High Sensitivity C-reactive Protein
|
-7.3715 ng/mL
Standard Error 3.9244
|
-3.1268 ng/mL
Standard Error 2.0415
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.
Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=20 Participants
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
n=19 Participants
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
|
|---|---|---|
|
Gingival Crevicular Fluid Interleukin-6
|
0.1422 pg/mL
Standard Error 0.5273
|
-0.00226 pg/mL
Standard Error 0.3245
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.
Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=20 Participants
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
n=19 Participants
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
|
|---|---|---|
|
Gingival Crevicular Fluid Interleukin-1 Beta
|
0.8775 pg/mL
Standard Error 4.7203
|
21.5816 pg/mL
Standard Error 8.0491
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsSerum high-sensitivity C-reactive protein is a measure of systemic inflammation.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=24 Participants
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
n=22 Participants
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
|
|---|---|---|
|
Serum High-sensitivity C-reactive Protein
|
-0.3695 mg/L
Standard Error 0.5558
|
0.7114 mg/L
Standard Error 0.7223
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsSerum high-sensitivity interleukin-6 is a measure of systemic inflammation.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=20 Participants
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
n=21 Participants
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
|
|---|---|---|
|
Serum High-sensitivity Interleukin-6
|
0.3295 pg/mL
Standard Error 0.4149
|
-0.0690 pg/mL
Standard Error 0.2633
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsSerum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=20 Participants
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
n=21 Participants
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
|
|---|---|---|
|
Serum Soluble Vascular Cell Adhesion Molecule
|
4.8829 ng/mL
Standard Error 24.3667
|
27.9409 ng/mL
Standard Error 19.6992
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsUrine N-Terminal Telopeptides are a measure of systemic bone turnover.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=21 Participants
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
n=19 Participants
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
|
|---|---|---|
|
Urine N-Terminal Telopeptides
|
103.3333 nM BCE
Standard Error 70.5656
|
61.8421 nM BCE
Standard Error 90.5793
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 monthsRed blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.
Outcome measures
| Measure |
Aspirin & Docosahexaenoic Acid
n=21 Participants
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
n=20 Participants
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
|
|---|---|---|
|
Change in Red Blood Cell Membrane Docosahexaenoic Acid
|
2.723 % of total RBC FA
Standard Error 0.3882
|
-0.1776 % of total RBC FA
Standard Error 0.1326
|
Adverse Events
DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)
n=27 participants at risk
|
Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)
n=28 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • Number of events 2 • 3 months
|
7.1%
2/28 • Number of events 2 • 3 months
|
|
Blood and lymphatic system disorders
Gingival bleeding while flossing
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
3/27 • Number of events 3 • 3 months
|
3.6%
1/28 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
General disorders
Fatigue
|
7.4%
2/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
General disorders
Headache
|
7.4%
2/27 • 3 months
|
0.00%
0/28 • 3 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
Infections and infestations
Cavity
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
Psychiatric disorders
Verbally abusive toward staff
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
General disorders
Chipped tooth
|
3.7%
1/27 • 3 months
|
0.00%
0/28 • 3 months
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/27 • 3 months
|
3.6%
1/28 • 3 months
|
|
Cardiac disorders
Intermittent palpitations
|
3.7%
1/27 • 3 months
|
0.00%
0/28 • 3 months
|
|
General disorders
Diaphoresis
|
3.7%
1/27 • 3 months
|
0.00%
0/28 • 3 months
|
Additional Information
Dr. Kenneth Mukamal
Beth Israel Deaconess Medical Center
Phone: 617-754-1401
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place