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Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

Primary Purpose

Periodontal Attachment Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty acid (with SRP or OHI)
Placebo
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Attachment Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fish oil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

clinical attachment loss

Secondary Outcome Measures

Full Information

First Posted
February 29, 2008
Last Updated
April 11, 2011
Sponsor
University of Kentucky
Collaborators
National Institutes of Health (NIH), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00632957
Brief Title
Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses
Official Title
Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kentucky
Collaborators
National Institutes of Health (NIH), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Attachment Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty acid (with SRP or OHI)
Intervention Description
1000mg capsules three times daily, duration 28 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
corn/soybean oil capsules 1g/three times daily
Primary Outcome Measure Information:
Title
clinical attachment loss
Time Frame
baseline, 8, 16, 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolph R. Dawson, DMD,MS
Organizational Affiliation
University of Kentucky College of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeff L. Ebersole, Ph.D
Organizational Affiliation
University of Kentucky College of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
M J Novak, Ph.D
Organizational Affiliation
University of Kentucky College of Dentistry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gilbert A. Boissonneault, Ph.D
Organizational Affiliation
University of Kentucky Division of Clinical Nutrition
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky College of Dentistry
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

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