ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00632957
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : April 12, 2011
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by:
University of Kentucky

February 29, 2008
March 11, 2008
April 12, 2011
September 2004
May 2009   (Final data collection date for primary outcome measure)
clinical attachment loss [ Time Frame: baseline, 8, 16, 28 weeks ]
Same as current
Complete list of historical versions of study NCT00632957 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Periodontal Attachment Loss
  • Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
    1000mg capsules three times daily, duration 28 weeks.
  • Dietary Supplement: Placebo
    corn/soybean oil capsules 1g/three times daily
  • Active Comparator: Fish oil
    Intervention: Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
200
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00632957
UK IRB # 04-0339-F1V
P20RR020145-04 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Dr. Jeff L. Ebersole, PI, Center for Oral Health Research
University of Kentucky
  • National Institutes of Health (NIH)
  • National Center for Research Resources (NCRR)
Principal Investigator: Dolph R. Dawson, DMD,MS University of Kentucky College of Dentistry
Study Chair: Jeff L. Ebersole, Ph.D University of Kentucky College of Dentistry
Study Director: M J Novak, Ph.D University of Kentucky College of Dentistry
Study Director: Gilbert A. Boissonneault, Ph.D University of Kentucky Division of Clinical Nutrition
University of Kentucky
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP