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Trial record 33 of 49 for:    gum disease AND oral | NIH

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

Tracking Information
First Submitted Date  ICMJE February 29, 2008
First Posted Date  ICMJE March 11, 2008
Last Update Posted Date April 12, 2011
Study Start Date  ICMJE September 2004
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
clinical attachment loss [ Time Frame: baseline, 8, 16, 28 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00632957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses
Official Title  ICMJE Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Periodontal Attachment Loss
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Fish oil
    Intervention: Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2011)
126
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2008)
200
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00632957
Other Study ID Numbers  ICMJE UK IRB # 04-0339-F1V
P20RR020145-04 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jeff L. Ebersole, PI, Center for Oral Health Research
Study Sponsor  ICMJE University of Kentucky
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
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
PRS Account University of Kentucky
Verification Date April 2011

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