The Effects of DHA on Periodontitis

Phase 2CompletedNCT01976806

Beth Israel Deaconess Medical Center55 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Periodontitis Gingivitis Inflammation

Interventions

AspirinDRUG

Docosahexaenoic acidDRUG

Placebo (for Docosahexaenoic acid)DRUG

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

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

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

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

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

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.

Data from ClinicalTrials.gov

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