Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

• Sponsor: University of Kentucky (Other)
• Overall Status: Completed
• CT.gov ID: NCT00632957
• Collaborator: National Institutes of Health (NIH) (NIH), National Center for Research Resources (NCRR) (NIH)
• Enrollment: 126
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Attachment Loss	Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI); Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. clinical attachment loss [baseline, 8, 16, 28 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky College of Dentistry	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• University of Kentucky
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00632957
• Other Study ID Numbers: UK IRB # 04-0339-F1V; P20RR020145-04
• First Posted: Mar 11, 2008
• Last Update Posted: Apr 12, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Periodontal Attachment Loss

Study Results

No Results Posted as of Apr 12, 2011