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Completed

NCT Number: NCT01976806

The Effects of DHA on Periodontitis

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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Key information

Conditions

Periodontitis Gingival Diseases Gingivitis Infections Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Other names: Baby Aspirin, Low Dose Aspirin

Docosahexaenoic Acid

Drug

Other names: DHA

Placebo (for Docosahexaenoic acid)

Drug

Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules

Other names: 50% corn oil/50% soybean oil

Primary outcomes

  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 outcomes

  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.

    • Mild inflammation, slight change in color, slight edema, no bleeding on probing.
    • Moderate inflammation, moderate glazing, redness, bleeding on probing.
    • 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

    • 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.
    • 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.
    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • National Center for Research Resources (NCRR)

Registry information

Official study title

The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial

Acronym: DAP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 6, 2013
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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