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Trial record 40 of 48 for:    gum disease | NIH

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

Brief Summary:
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.

Condition or disease Intervention/treatment Phase
Periodontitis Gingivitis Inflammation Drug: Aspirin Drug: Docosahexaenoic acid Drug: Placebo (for Docosahexaenoic acid) Phase 2

Detailed Description:
  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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial
Study Start Date : June 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Aspirin
Other Names:
  • Baby Aspirin
  • Low Dose Aspirin

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
Drug: Aspirin
Other Names:
  • Baby Aspirin
  • Low Dose Aspirin

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Serum High-sensitivity C-reactive Protein [ Time Frame: Baseline and 3 months ]
    Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.

  8. Serum High-sensitivity Interleukin-6 [ Time Frame: Baseline and 3 months ]
    Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.

  9. 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.

  10. Urine N-Terminal Telopeptides [ Time Frame: Baseline and 3 months ]
    Urine N-Terminal Telopeptides are a measure of systemic bone turnover.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Center for Research Resources (NCRR)
Harvard Medical School
Investigators
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

Publications of Results:
Other Publications:
Responsible Party: Kenneth Mukamal, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01976806     History of Changes
Other Study ID Numbers: GM-023
UL1RR025758-02 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2013    Key Record Dates
Results First Posted: March 24, 2014
Last Update Posted: December 13, 2017
Last Verified: November 2017

Keywords provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:
Docosahexaenoic acid
DHA
Periodontitis
Gingivitis
Omega-3 fatty acid
Fish oil

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Inflammation
Periodontitis
Gingivitis
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics