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Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00632957
First received: February 29, 2008
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Periodontal Attachment Loss
 Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • clinical attachment loss [ Time Frame: baseline, 8, 16, 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: September 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fish oil Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
1000mg capsules three times daily, duration 28 weeks.
Placebo Comparator: Placebo Dietary Supplement: Placebo
corn/soybean oil capsules 1g/three times daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632957

Locations
United States, Kentucky
University of Kentucky College of Dentistry
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Investigators
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
  More Information

Additional Information:
Current studies at Delta Dental of Kentucky Clinical Research Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Jeff L. Ebersole, PI, Center for Oral Health Research
ClinicalTrials.gov Identifier: NCT00632957     History of Changes
Other Study ID Numbers: UK IRB # 04-0339-F1V, P20 RR020145-04
Study First Received: February 29, 2008
Last Updated: April 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Periodontal Attachment Loss
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013