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
About this trial
This is an interventional treatment trial for Periodontal Attachment Loss
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
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
NCT ID
NCT00632957
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)
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
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Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses
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