The Effects of DHA on Periodontitis

Browse trials for

• Gingivitis 590
• Periodontitis 1,635
• Inflammation 3,439

Keywords

• Docosahexaenoic acid
• DHA
• Periodontitis
• Gingivitis
• Omega-3 fatty acid
• Fish oil

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 55 is below the median of 64 across 478 interventional studies indexed under Gingivitis.

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Study arms

• 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 · 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

  Drug: Aspirin · Drug: Placebo (for Docosahexaenoic acid)

Interventions

• DrugAspirin

  Also known as: Baby Aspirin, Low Dose Aspirin

• DrugDocosahexaenoic acid

  Also known as: DHA

• DrugPlacebo (for Docosahexaenoic acid)

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

  Also known as: 50% corn oil/50% soybean oil

Primary outcomes

1. Change in Pocket Depth (mm)

   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).

   Time frame: Baseline and 3 months

Secondary outcomes

1. Change in Gingival Index (0-3)

   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.

   Time frame: Baseline and 3 months

2. Change in Plaque Index (0-3)

   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.

   Time frame: Baseline and 3 months

3. Sites With Bleeding on Probing (Yes/no)

   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.

   Time frame: 3 months

4. Gingival Crevicular Fluid High Sensitivity C-reactive Protein

   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.

   Time frame: Baseline and 3 months

5. Gingival Crevicular Fluid Interleukin-6

   Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.

   Time frame: Baseline and 3 months

6. Gingival Crevicular Fluid Interleukin-1 Beta

   Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.

   Time frame: Baseline and 3 months

7. Serum High-sensitivity C-reactive Protein

   Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.

   Time frame: Baseline and 3 months

8. Serum High-sensitivity Interleukin-6

   Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.

   Time frame: Baseline and 3 months

9. Serum Soluble Vascular Cell Adhesion Molecule

   Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.

   Time frame: Baseline and 3 months

10. Urine N-Terminal Telopeptides

    Urine N-Terminal Telopeptides are a measure of systemic bone turnover.

    Time frame: Baseline and 3 months

Other outcomes

1. Change in Red Blood Cell Membrane Docosahexaenoic Acid

   Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.

   Time frame: Baseline and 3 months

Baseline characteristics

Publications

• Naqvi AZ, Mu L, Hasturk H, Van Dyke TE, Mukamal KJ, Goodson JM. Impact of Docosahexaenoic Acid Therapy on Subgingival Plaque Microbiota. J Periodontol. 2017 Sep;88(9):887-895. doi: 10.1902/jop.2017.160398. Epub 2017 May 18. PubMed 28517974 ↗
• Naqvi AZ, Hasturk H, Mu L, Phillips RS, Davis RB, Halem S, Campos H, Goodson JM, Van Dyke TE, Mukamal KJ. Docosahexaenoic Acid and Periodontitis in Adults: A Randomized Controlled Trial. J Dent Res. 2014 Aug;93(8):767-73. doi: 10.1177/0022034514541125. Epub 2014 Jun 26. PubMed 24970858 ↗