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The Effects of DHA on Periodontitis (DAP)

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ClinicalTrials.gov Identifier: NCT01976806
Recruitment Status : Completed
First Posted : November 6, 2013
Results First Posted : March 24, 2014
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Harvard Medical School
Information provided by (Responsible Party):
Kenneth Mukamal, Beth Israel Deaconess Medical Center

October 30, 2013
November 6, 2013
December 3, 2013
March 24, 2014
December 13, 2017
June 2009
September 2011   (Final data collection date for primary outcome measure)
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 Pocket Depth (mm) [ Time Frame: 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 >5 mm.
Complete list of historical versions of study NCT01976806 on ClinicalTrials.gov Archive Site
  • 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). 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.
  • 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. 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.
  • 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 Gingival Index (0-3) [ Time Frame: 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.
  • Change in Plaque Index (0-3) [ Time Frame: 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.
  • Change in 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: 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: 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: 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: 3 months ]
    Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.
  • Serum High-sensitivity Interleukin-6 [ Time Frame: 3 months ]
    Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.
  • Serum Soluble Vascular Cell Adhesion Molecule [ Time Frame: 3 months ]
    Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.
  • Urine N-Terminal Telopeptides [ Time Frame: 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.
  • Change in Red Blood Cell Membrane Docosahexaenoic Acid [ Time Frame: 3 months ]
    Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.
  • Vital Signs [ Time Frame: 3 months ]
    Baseline and follow-up vital signs, including temperature, blood pressure, heart rate were measured to assess for safety and eligibility (uncontrolled hypertensives were excluded).
  • Serum Fasting Lipid Profile [ Time Frame: 3 months ]
    Baseline and follow-up fasting lipid profiles were measured for descriptive purposes of our study population.
  • Serum Complete Blood Count [ Time Frame: 3 months ]
    Baseline and 3 month follow-up complete blood counts were measured for descriptive purposes of our study population and for safety.
  • Urine Beta-human Chorionic Gonadotropin [ Time Frame: Baseline ]
    Urine beta-human chorionic gonadotropin was measured in all female subjects for eligibility (pregnant females excluded for safety).
 
The Effects of DHA on Periodontitis
The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.
  1. 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.
  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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Periodontitis
  • Gingivitis
  • Inflammation
  • Drug: Aspirin
    Other Names:
    • Baby Aspirin
    • Low Dose Aspirin
  • Drug: Docosahexaenoic acid
    Other Name: DHA
  • 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
  • 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
    Interventions:
    • Drug: Aspirin
    • Drug: Docosahexaenoic acid
  • 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
    Interventions:
    • Drug: Aspirin
    • Drug: Placebo (for Docosahexaenoic acid)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
125
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >40 years
  • >20 natural teeth (excluding third molars)
  • no orthodontic appliances
  • periodontitis defined as >4 teeth with pocket probing depths >5 mm

Exclusion Criteria:

  • pregnancy
  • diabetes
  • severe chronic diseases
  • gastrointestinal bleeding
  • uncontrolled chronic diseases
  • autoimmune disorders
  • conditions requiring antibiotic prophylaxis
  • warfarin
  • clopidogrel
  • antimicrobial therapy within 30 days
  • chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)
  • omega-3 fatty acid use within 6 months
  • loose teeth
  • painful teeth
  • periodontal abscess
  • pocket depths >10 mm in >1 tooth
  • periodontal therapy within the past two years
  • allergy to aspirin
  • allergy to fish oil
  • allergy to corn oil
  • allergy to soybean oil
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01976806
GM-023
UL1RR025758-02 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Kenneth Mukamal, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • National Center for Research Resources (NCRR)
  • Harvard Medical School
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
Beth Israel Deaconess Medical Center
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP