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.

Study Overview

• Status: Completed
• Conditions: Periodontal Attachment Loss
• Intervention / Treatment: Dietary supplement: Omega-3 Fatty acid (with SRP or OHI); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; corn/soybean oil capsules 1g/three times daily
Active Comparator: Fish oil	Dietary supplement: Omega-3 Fatty acid (with SRP or OHI); 1000mg capsules three times daily, duration 28 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical attachment loss	baseline, 8, 16, 28 weeks

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 11, 2008

Study Record Updates

• Last Update Posted (Estimate): April 12, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Periodontal Attachment Loss
• Other Study ID Numbers: UK IRB # 04-0339-F1V; P20RR020145-04 (U.S. NIH Grant/Contract)