The Effects of DHA on Periodontitis (DAP)

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Periodontitis; Inflammation; Gingivitis

Treatments: Drug: Placebo (for Docosahexaenoic acid); Drug: Docosahexaenoic acid; Drug: Aspirin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01976806

UL1RR025758-02 (U.S. NIH Grant/Contract)

GM-023

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

Aspirin & Docosahexaenoic acid

Experimental group

Description:

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

Treatment:

Drug: Aspirin

Drug: Docosahexaenoic acid

Aspirin & Placebo

Active Comparator group

Description:

Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months

Treatment:

Drug: Aspirin

Drug: Placebo (for Docosahexaenoic acid)