Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

Periodontal Attachment Loss Clinical Trial

Official title:

Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632957
• Other study ID #: UK IRB # 04-0339-F1V
• Secondary ID: P20RR020145-04
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: April 11, 2011
• Start date: September 2004
• Est. completion date: May 2009

Study information

• Verified date: April 2011
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontal Attachment Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Kentucky College of Dentistry	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Kentucky	National Center for Research Resources (NCRR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical attachment loss		baseline, 8, 16, 28 weeks	No

External Links

•   Current studies at Delta Dental of Kentucky Clinical Research Center