Trial · NCT01976806

The Effects of DHA on Periodontitis

NCT01976806, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2014-03-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effects of DHA on Periodontitis. Trials, record NCT01976806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976806

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Effects of DHA on Periodontitis
NCT number: NCT01976806
Status: Completed
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: Beth Israel Deaconess Medical Center
Conditions: Periodontitis, Gingivitis, Inflammation
Interventions: Aspirin, Docosahexaenoic acid, Placebo (for Docosahexaenoic acid)
First posted: 2013-11-06
Last updated: 2017-12-13
Results first posted: 2014-03-24

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Pocket Depth (mm)	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).
Secondary	Change in Gingival Index (0-3)	Baseline and 3 months	Gingival 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.
Secondary	Change in Plaque Index (0-3)	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. 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.
Secondary	Sites With Bleeding on Probing (Yes/no)	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.
Secondary	Gingival Crevicular Fluid High Sensitivity C-reactive Protein	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.
Secondary	Gingival Crevicular Fluid Interleukin-6	Baseline and 3 months	Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.
Secondary	Gingival Crevicular Fluid Interleukin-1 Beta	Baseline and 3 months	Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.
Secondary	Serum High-sensitivity C-reactive Protein	Baseline and 3 months	Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.
Secondary	Serum High-sensitivity Interleukin-6	Baseline and 3 months	Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.
Secondary	Serum Soluble Vascular Cell Adhesion Molecule	Baseline and 3 months	Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Pocket Depth (mm)	Baseline and 3 months		mm	MEAN
SECONDARY	Change in Gingival Index (0-3)	Baseline and 3 months		GI units	MEAN
SECONDARY	Change in Plaque Index (0-3)	Baseline and 3 months		Plaque index units	MEAN
SECONDARY	Sites With Bleeding on Probing (Yes/no)	3 months	Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript.	Sites	COUNT_OF_UNITS
SECONDARY	Gingival Crevicular Fluid High Sensitivity C-reactive Protein	Baseline and 3 months	Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.	ng/mL	MEAN
SECONDARY	Gingival Crevicular Fluid Interleukin-6	Baseline and 3 months	Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.	pg/mL	MEAN
SECONDARY	Gingival Crevicular Fluid Interleukin-1 Beta	Baseline and 3 months	Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.	pg/mL	MEAN
SECONDARY	Serum High-sensitivity C-reactive Protein	Baseline and 3 months		mg/L	MEAN
SECONDARY	Serum High-sensitivity Interleukin-6	Baseline and 3 months		pg/mL	MEAN
SECONDARY	Serum Soluble Vascular Cell Adhesion Molecule	Baseline and 3 months		ng/mL	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Pocket Depth (mm)	Aspirin & Docosahexaenoic Acid	-0.71	Standard Error 0.07	mm
Change in Pocket Depth (mm)	Aspirin & Placebo	-0.54	Standard Error 0.07	mm
Change in Gingival Index (0-3)	Aspirin & Docosahexaenoic Acid	-0.26	Standard Error 0.04	GI units
Change in Gingival Index (0-3)	Aspirin & Placebo	-0.07	Standard Error 0.04	GI units
Change in Plaque Index (0-3)	Aspirin & Docosahexaenoic Acid	-0.10	Standard Error 0.06	Plaque index units
Change in Plaque Index (0-3)	Aspirin & Placebo	0.07	Standard Error 0.07	Plaque index units
Sites With Bleeding on Probing (Yes/no)	Aspirin & Docosahexaenoic Acid	202		Sites
Sites With Bleeding on Probing (Yes/no)	Aspirin & Placebo	227		Sites
Gingival Crevicular Fluid High Sensitivity C-reactive Protein	Aspirin & Docosahexaenoic Acid	-7.3715	Standard Error 3.9244	ng/mL
Gingival Crevicular Fluid High Sensitivity C-reactive Protein	Aspirin & Placebo	-3.1268	Standard Error 2.0415	ng/mL

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aspirin & Docosahexaenoic Acid	27
Overall Study	STARTED	Aspirin & Placebo	28
Overall Study	COMPLETED	Aspirin & Docosahexaenoic Acid	24
Overall Study	COMPLETED	Aspirin & Placebo	22
Overall Study	NOT COMPLETED	Aspirin & Docosahexaenoic Acid	3
Overall Study	NOT COMPLETED	Aspirin & Placebo	6

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dyspepsia	Gastrointestinal disorders	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	2	27	2
other	Dyspepsia	Gastrointestinal disorders	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	2	28	2
other	Gingival bleeding while flossing	Blood and lymphatic system disorders	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	0	27	0
other	Gingival bleeding while flossing	Blood and lymphatic system disorders	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	1	28	1
other	Flatulence	Gastrointestinal disorders	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	3	27	3
other	Flatulence	Gastrointestinal disorders	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	1	28	1
other	Diarrhea	Gastrointestinal disorders	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	1	27
other	Diarrhea	Gastrointestinal disorders	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	1	28
other	Fatigue	General disorders	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	2	27
other	Fatigue	General disorders	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	1	28

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)
Total, all-cause mortality	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)
Total, other adverse events	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	7	27
Total, other adverse events	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	8	28
Total, serious adverse events	DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	0	27
Total, serious adverse events	Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)	0	28

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24970858	RESULT	PubMed
28517974	BACKGROUND	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UL1RR025758	Harvard Clinical and Translational Science Center (UL1)	NADLER, LEE MARSHALL	HARVARD MEDICAL SCHOOL	NATIONAL CENTER FOR RESEARCH RESOURCES	2008 to 2011

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day) vs Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01976806

GET https://conductscience.org/api/trials/v1/NCT01976806/results?page=2

API reference For AI assistants