Oral Infections: Dietary Regulation of Local and Systemic... | NCT00632957

Studies
Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

NCT00632957

Sponsor

University of Kentucky

Status

Completed

Last Update Posted

Apr 12, 2011Estimated

Enrollment

126Actual

Phase

Not Applicable

Conditions

Periodontal Attachment Loss

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P20RR020145-04	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Feb 29, 2008

First Submission Date that Met QC Criteria

Mar 10, 2008

First Posted Date

Mar 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2011

Last Update Posted Date

Apr 12, 2011Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Center for Research Resources (NCRR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fish oil	Active Comparator		Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 Fatty acid (with SRP or OHI)	Dietary Supplement	1000mg capsules three times daily, duration 28 weeks.	Fish oil

Measure	Description	Time Frame
clinical attachment loss		baseline, 8, 16, 28 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky College of Dentistry		Lexington	Kentucky	40536	United States

Condition Browse Module

MeSH Terms

ID	Term
D017622	Periodontal Attachment Loss

Ancestor Terms

ID	Term
D055093	Periodontal Atrophy
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015525	Fatty Acids, Omega-3

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided