Skip to content

Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00632957
Enrollment
126
Registered
2008-03-11
Start date
2004-09-30
Completion date
2009-05-31
Last updated
2011-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Attachment Loss

Brief summary

The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.

Interventions

DIETARY_SUPPLEMENTOmega-3 Fatty acid (with SRP or OHI)

1000mg capsules three times daily, duration 28 weeks.

DIETARY_SUPPLEMENTPlacebo

corn/soybean oil capsules 1g/three times daily

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Center for Research Resources (NCRR)
CollaboratorNIH
University of Kentucky
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. ≥ 18 years of age, male or female 2. At least 20 natural teeth present at the time of periodontal examination 3. Be diagnosed with severe, chronic periodontitis; 4. Be willing to participate in the study

Exclusion criteria

1. \<18 years of age 2. Less than 20 natural teeth present at time of periodontal examination 3. Unable or unwilling to provide informed consent or follow study protocol 4. Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment 5. Use of systemic antibiotics within the last 3 months 6. Pregnancy as diagnosed by administered pregnancy test. 7. You are nursing a baby. 8. Are allergic to fish or fish products. 9. You are taking any other medications, such as dietary supplements, that could affect the outcome of the study

Design outcomes

Primary

MeasureTime frame
clinical attachment lossbaseline, 8, 16, 28 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026