The Effects of DHA on Periodontitis

Se sèlman itilizatè ki anrejistre yo ki ka tradwi atik yo

Lyen an sove nan clipboard la

EstatiKonplete

Patwone

Beth Israel Deaconess Medical Center

Kolaboratè

National Center for Research Resources (NCRR)

Harvard Medical School

ESÈ KLINIK: NCT01976806

BioSeek: NCT01976806

Mo kle

Abstrè

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

Deskripsyon

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.

Dat

Dènye verifye:	10/31/2017
Premye Soumèt:	10/29/2013
Enskripsyon Estimasyon Soumèt:	10/29/2013
Premye afiche:	11/05/2013
Dènye Mizajou Soumèt:	11/16/2017
Dènye Mizajou afiche:	12/12/2017
Dat premye rezilta yo soumèt:	12/02/2013
Dat premye rezilta QC yo soumèt:	02/22/2014
Dat premye rezilta ki afiche yo:	03/23/2014
Dat aktyèl kòmanse etid la:	05/31/2009
Dat Estimasyon Prensipal Estimasyon an:	08/31/2011
Dat estime fini etid la:	08/31/2011

Kondisyon oswa maladi

Periodontitis

Gingivitis

Inflammation

Entèvansyon / tretman

Drug: Aspirin

Drug: Aspirin & Docosahexaenoic acid

Drug: Aspirin & Placebo

Faz

Faz 2

Gwoup bra

Bra	Entèvansyon / tretman
Experimental: Aspirin & Docosahexaenoic acid 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 & Docosahexaenoic acid
Active Comparator: Aspirin & Placebo Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months	Drug: Aspirin & Placebo Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules

Kritè kalifikasyon yo

Laj ki kalifye pou etid	40 Years Pou 40 Years
Sèks ki kalifye pou etid	All
Aksepte Volontè Healthy	Wi
Kritè	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

Rezilta

Mezi Rezilta Prensipal yo

1. Change in Pocket Depth (mm) [Baseline and 3 months]

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).

Mezi Rezilta Segondè

1. Change in Gingival Index (0-3) [Baseline and 3 months]

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.

2. Change in Plaque Index (0-3) [Baseline and 3 months]

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.

3. Sites With Bleeding on Probing (Yes/no) [3 months]

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.

4. Gingival Crevicular Fluid High Sensitivity C-reactive Protein [Baseline and 3 months]

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.

5. Gingival Crevicular Fluid Interleukin-6 [Baseline and 3 months]

Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.

6. Gingival Crevicular Fluid Interleukin-1 Beta [Baseline and 3 months]

Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.

7. Serum High-sensitivity C-reactive Protein [Baseline and 3 months]

Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.

8. Serum High-sensitivity Interleukin-6 [Baseline and 3 months]

Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.

9. Serum Soluble Vascular Cell Adhesion Molecule [Baseline and 3 months]

Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.

10. Urine N-Terminal Telopeptides [Baseline and 3 months]

Urine N-Terminal Telopeptides are a measure of systemic bone turnover.

Lòt Mezi Rezilta

1. Change in Red Blood Cell Membrane Docosahexaenoic Acid [Baseline and 3 months]

Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.

The Effects of DHA on Periodontitis

Mo kle

hemorrhage

inflammation

periodontitis

dental plaque

docosahexaenoic acid