Impact of Gum Infection on Heart Disease

NCT00093236 | Completed DMC

• 2 other identifiers: H-23262R01DE015345
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of gum infection on parameters of cardio-vascular disease.

Conditions

Cardiovascular Disease; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Periodontal disease progression

  Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health. During this period, the Usual Hygiene Group will return for oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.

  3 wks, 12 wks, and 24 weeks

Study Arms (2)

Early Periodontal Treatment

EXPERIMENTAL

Subjects will receive scaling, root planing and if needed periodontal surgery

Procedure: Early Periodontal Treatment

Usual Dental Hygiene

ACTIVE COMPARATOR

Subjects will receive routine oral hygiene

Procedure: Usual Dental Hygiene

Interventions

Early Periodontal Treatment PROCEDURE

Subjects will receive scaling and root planing at baseline. Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health.comprehensive periodontal treatment

Early Periodontal Treatment

Usual Dental Hygiene PROCEDURE

Subjects will receive routine oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.

Usual Dental Hygiene

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems.
• In this intervention study, cigarette smokers will be permitted as justified below and randomized in stratified fashion to ensure equal numbers in the two treatment groups.

You may not qualify if:

• Known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure.
• Major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the ATP-III guidelines.
• Other major illness including cancer, liver disease, renal disease, pulmonary disease, chronic infectious disease (including HIV and hepatitis C infection), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy.
• Use of antibiotics within three months.
• Use of oral contraceptives or hormone replacement therapy.
• Major psychiatric illness requiring treatment or that might interfere with the ability to understand and cooperate with the protocol.
• Ongoing drug or alcohol abuse.
• Use of sildenafil (Viagra) within 7 days because of the risk of marked hypotension with nitroglycerin administration.
• History of migraine headaches that might be exacerbated by nitroglycerin.
• Use of cholesterol lowering therapy, angiotensin converting enzyme inhibitors (subjects should not be taking these drugs because they will have no history of cardiovascular disease risk factors).
• Antioxidant vitamins (vitamin C or vitamin E) in doses exceeding the Recommended Dietary Allowances (RDA), (60 mg/day and 30 IU/day, respectively).
• Pregnancy, as diagnosed by serum beta-hCG.

Sponsors & Collaborators

• Boston University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Salomon Amar, DMD, Ph.D

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2004
• First Posted: October 7, 2004
• Study Start: September 1, 2004
• Primary Completion: April 1, 2011
• Study Completion: December 8, 2012
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)