Expired Study
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Lexington, Kentucky 40536


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.


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


Study is Available At:


Original ID:

UK IRB # 04-0339-F1V


NCT ID:

NCT00632957


Secondary ID:

P20 RR020145-04


Study Acronym:


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.


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kentucky


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

126


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dolph R. Dawson, DMD,MS
Principal Investigator
University of Kentucky College of Dentistry

Study Dates

Start Date:September 2004
Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 11, 2011
First Received Date:February 29, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:clinical attachment loss
Time Frame:baseline, 8, 16, 28 weeks
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Omega-3 Fatty acid (with SRP or OHI)
Description:1000mg capsules three times daily, duration 28 weeks.
Arm Name:Fish oil
Intervention Type:Dietary Supplement
Name:Placebo
Description:corn/soybean oil capsules 1g/three times daily
Arm Name:Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:Fish oil
Study Arm Type:Placebo Comparator
Arm Name:Placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kentucky
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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