Phase 2 N=55 Randomized Triple-blind Treatment

The Effects of DHA on Periodontitis

Periodontitis · Gingivitis · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT01976806 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Change in Pocket Depth (mm) — -0.71; -0.54 mm — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aspirin (Drug); Docosahexaenoic acid (Drug); Placebo (for Docosahexaenoic acid) (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pocket Depth (mm)	-0.71; -0.54	<0.05 sig
SECONDARY Change in Gingival Index (0-3)	-0.26; -0.07	—
SECONDARY Change in Plaque Index (0-3)	-0.10; 0.07	—
SECONDARY Sites With Bleeding on Probing (Yes/no)	202; 227	—
SECONDARY Gingival Crevicular Fluid High Sensitivity C-reactive Protein	-7.3715; -3.1268	—
SECONDARY Gingival Crevicular Fluid Interleukin-6	0.1422; -0.00226	—
SECONDARY Gingival Crevicular Fluid Interleukin-1 Beta	0.8775; 21.5816	—
SECONDARY Serum High-sensitivity C-reactive Protein	-0.3695; 0.7114	—
SECONDARY Serum High-sensitivity Interleukin-6	0.3295; -0.0690	—
SECONDARY Serum Soluble Vascular Cell Adhesion Molecule	4.8829; 27.9409	—
SECONDARY Urine N-Terminal Telopeptides	103.3333; 61.8421	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01976806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.