The Effects of DHA on Periodontitis

NCT01976806 | Completed Phase 2 Results

• 2 other identifiers: GM-023UL1RR025758-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis; Gingivitis; Inflammation

Keywords

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

Outcome Measures

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).

  Baseline and 3 months

Secondary Outcomes (10)

• Change in Gingival Index (0-3)

  Baseline and 3 months

• Change in Plaque Index (0-3)

  Baseline and 3 months

• Sites With Bleeding on Probing (Yes/no)

  3 months

• Gingival Crevicular Fluid High Sensitivity C-reactive Protein

  Baseline and 3 months

• Gingival Crevicular Fluid Interleukin-6

  Baseline and 3 months

Other Outcomes (1)

• Change in Red Blood Cell Membrane Docosahexaenoic Acid

  Baseline and 3 months

Study Arms (2)

Aspirin & Docosahexaenoic acid

EXPERIMENTAL

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

Aspirin & Placebo

ACTIVE COMPARATOR

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

Aspirin DRUG

Also known as: Baby Aspirin, Low Dose Aspirin

Aspirin & Docosahexaenoic acid; Aspirin & Placebo

Docosahexaenoic acid DRUG

Also known as: DHA

Aspirin & Docosahexaenoic acid

Placebo (for Docosahexaenoic acid) DRUG

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

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

Aspirin & Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Center for Research Resources (NCRR): collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 28517974 BACKGROUND

• 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.

  PMID: 24970858 RESULT

MeSH Terms

Conditions

Periodontitis; Gingivitis; Inflammation

Interventions

Aspirin; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. Kenneth Mukamal
• Organization: Beth Israel Deaconess Medical Center

kmukamal@bidmc.harvard.edu

617-754-1401

Study Officials

• Asghar Z Naqvi, MD, MPH, MNS

  Beth Israel Deaconess Medical Center; Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Kenneth J Mukamal, MD, MPH, MA

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 13, 2017
• Results First Posted: March 24, 2014

Record last verified: 2017-11

Locations

US (1)