NCT00066053

Brief Summary

The purpose of this study is to determine if treating periodontal infections (gum problems) will lead to fewer heart problems in patients at high risk for cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

August 5, 2011

Status Verified

May 1, 2007

Enrollment Period

2.4 years

First QC Date

August 1, 2003

Last Update Submit

August 4, 2011

Conditions

Cardiovascular DiseaseCoronary Heart DiseaseMyocardial InfarctionCerebrovascular Accident

Keywords

Heart attacksStrokeAngina

Outcome Measures

Primary Outcomes (1)

  • Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke.

    One year

Study Arms (2)

Periodontal Treatment: SRP

EXPERIMENTAL

Comprehensive scaling \& root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions.

Procedure: Periodontal Treatment: SRP

Community Comparator

ACTIVE COMPARATOR

Referral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment.

Procedure: Referral

Interventions

Periodontal Treatment: SRPPROCEDURE

Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.

Also known as: Treatment of periodontal infections.
Periodontal Treatment: SRP
ReferralPROCEDURE
Community Comparator

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Any of the following:
  • A major illness requiring hospitalization,
  • Renal dialysis,
  • Serum creatinine \> 3 mg/dl,
  • Organ transplant recipient requiring immunosuppression medication,
  • Surgery needed in the next 3 years,
  • Chemotherapy in the past 3 years,
  • Head and/or neck radiation at any time in the past,
  • Liver dysfunction,
  • Class IV congestive heart failure,
  • Drug or alcohol abuse,
  • Pacemaker or AICD/defibrillator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseMyocardial InfarctionStrokeAngina Pectoris

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Sara G Grossi, DDS, MS

    University at Buffalo

    PRINCIPAL INVESTIGATOR

  • Thomas E van Dyke, DDS,MS

    Goldman School of Dental Medicine, Boston, MA

    PRINCIPAL INVESTIGATOR

  • John C Gunsolley, DDS,MS

    University of Maryland, Dept. of Periodontics, Baltimore, MD

    PRINCIPAL INVESTIGATOR

  • James D Beck, Ph.D

    University of NC, School of Dentistry, Chapel Hill, NC

    PRINCIPAL INVESTIGATOR

  • Lloyd E Chambless, PhD,

    University of NC, Dept. of Biostatistics, Chapel Hill, NC

    PRINCIPAL INVESTIGATOR

  • Steven Offenbacher, DDS,PhD,MMSc

    University of NC, Comprehensive Cntr. for Inflammatory Diseases, Chapel Hill, NC

    PRINCIPAL INVESTIGATOR

  • Theresa Madden, DDS, PhD

    Oregon Health and Science University, Portland, OR

    PRINCIPAL INVESTIGATOR

  • Gerardo Maupome, PhD

    Kaiser-Permanente Center for Health Research, Portland, OR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

January 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

August 5, 2011

Record last verified: 2007-05

Locations

US(1)