The Effects of DHA on Periodontitis

Inflammation Clinical Trial

— DAP  

Official title:

The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976806
• Other study ID #: GM-023
• Secondary ID: UL1RR025758-02
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2013
• Last updated: November 17, 2017
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: November 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Inflammation
• Periodontitis

Intervention

Drug:
• Aspirin

• Docosahexaenoic acid

• Placebo (for Docosahexaenoic acid)
Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Harvard Medical School, National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Ep — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline and 3 months
Primary	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	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.; Mild inflammation, slight change in color, slight edema, no bleeding on probing.; Moderate inflammation, moderate glazing, redness, bleeding on probing.; Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.	Baseline and 3 months
Secondary	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; 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.; 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.; Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.	Baseline and 3 months
Secondary	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.	3 months
Secondary	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.	Baseline and 3 months
Secondary	Gingival Crevicular Fluid Interleukin-6	Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.	Baseline and 3 months
Secondary	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.	Baseline and 3 months
Secondary	Serum High-sensitivity C-reactive Protein	Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.	Baseline and 3 months
Secondary	Serum High-sensitivity Interleukin-6	Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.	Baseline and 3 months
Secondary	Serum Soluble Vascular Cell Adhesion Molecule	Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.	Baseline and 3 months
Secondary	Urine N-Terminal Telopeptides	Urine N-Terminal Telopeptides are a measure of systemic bone turnover.	Baseline and 3 months