Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

NCT00632957 | Completed

• 2 other identifiers: UK IRB # 04-0339-F1VP20RR020145-04
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (1)

• clinical attachment loss

  baseline, 8, 16, 28 weeks

Study Arms (2)

Fish oil

ACTIVE COMPARATOR

Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Omega-3 Fatty acid (with SRP or OHI) DIETARY_SUPPLEMENT

1000mg capsules three times daily, duration 28 weeks.

Fish oil

Placebo DIETARY_SUPPLEMENT

corn/soybean oil capsules 1g/three times daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Kentucky: lead
• National Institutes of Health (NIH): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University of Kentucky College of Dentistry

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Periodontal Attachment Loss

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Dolph R. Dawson, DMD,MS

  University of Kentucky College of Dentistry

  PRINCIPAL INVESTIGATOR

• Jeff L. Ebersole, Ph.D

  University of Kentucky College of Dentistry

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: September 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 12, 2011

Record last verified: 2011-04

Locations

US (1)