Clinical trial NCT01976806: The Effects of DHA on Periodontitis
Official title: The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Gingivitis
Inflammation
Keywords: Docosahexaenoic acid
DHA
Periodontitis
Gingivitis
Omega-3 fatty acid
Fish oil
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: Harvard Medical School (HMS and HSDM)
First posted: 2013-11-06
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pocket Depth (mm)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Gingival Index (0-3)
timeFrame: Baseline and 3 months
measure: Change in Plaque Index (0-3)
timeFrame: Baseline and 3 months
measure: Sites With Bleeding on Probing (Yes/no)
timeFrame: 3 months
measure: Gingival Crevicular Fluid High Sensitivity C-reactive Protein
timeFrame: Baseline and 3 months
measure: Gingival Crevicular Fluid Interleukin-6
timeFrame: Baseline and 3 months
measure: Gingival Crevicular Fluid Interleukin-1 Beta
timeFrame: Baseline and 3 months
measure: Serum High-sensitivity C-reactive Protein
timeFrame: Baseline and 3 months
measure: Serum High-sensitivity Interleukin-6
timeFrame: Baseline and 3 months
measure: Serum Soluble Vascular Cell Adhesion Molecule
timeFrame: Baseline and 3 months
measure: Urine N-Terminal Telopeptides
timeFrame: Baseline and 3 months
Other outcomes:
measure: Change in Red Blood Cell Membrane Docosahexaenoic Acid
timeFrame: Baseline and 3 months
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center; Harvard Medical School
name: Asghar Z Naqvi, MD, MPH, MNS
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Kenneth J Mukamal, MD, MPH, MA
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.