Skip to main content
OpenTrials
Completed

NCT Number: NCT00632957

Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontal Attachment Loss Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky College of Dentistry

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Omega-3 Fatty acid (with SRP or OHI)

Dietary Supplement

1000mg capsules three times daily, duration 28 weeks.

Placebo

Dietary Supplement

corn/soybean oil capsules 1g/three times daily

Primary outcomes

  1. clinical attachment loss

    Time frame: baseline, 8, 16, 28 weeks

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Mar 11, 2008
Registry last updated
Apr 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.