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Effect of Intensive Periodontal Therapy on Vascular Function

This study has been completed.
Sponsor:
Collaborators:
University College London Hospitals
British Heart Foundation
The European Research Group on Periodontology (ERGOPerio)
Johnson & Johnson
CORDA, The Heart Charity
The European Social Fund
Italian Society of Periodontology
Information provided by:
Eastman Dental Insitute and Hospital
ClinicalTrials.gov Identifier:
NCT00327561
First received: May 16, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted
  Purpose

The hypothesis of the existence of a causal association between the systemic infectious/inflammatory burden represented by periodontitis and endothelial function assessed by flow mediated dilatation of the brachial artery (FMD) is the subject of the proposed investigation.

The objective of this randomized controlled clinical trial is to evaluate the effects of periodontal therapy on endothelial function assessed by Flow mediated dilatation (FMD).

The rationale for this project is twofold:

  • Establish the extent of acute systemic inflammation and endothelial dysfunction associated with the delivery of subgingival instrumentation for the treatment of chronic periodontitis
  • Establish whether or not improved control of chronic periodontal infections results in improved endothelial function and thus the existence of a causal association between periodontitis and endothelial dysfunction.

Condition Intervention Phase
Periodontitis
 Procedure: Intensive periodontal therapy
Procedure: Community based periodontal therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Non-Surgical Periodontal Therapy on Endothelial Function A Randomized Controlled Clinical Trial

Further study details as provided by Eastman Dental Insitute and Hospital:

Primary Outcome Measures:
  • Flow mediated dilatation of the brachial artery

Secondary Outcome Measures:
  • Serum inflammatory and endothelial function markers

Estimated Enrollment: 120
Study Start Date: September 2003
Estimated Study Completion Date: March 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 35 and 60 and in good general health.
  • Ability and willingness to follow study procedures and instructions.
  • Must have read, understood and signed the Informed Consent.
  • Must have generalized, moderate to advanced chronic periodontitis.
  • 40-100 pockets with a PD of > 5 must bleed on probing.
  • Absence of other significant oral infections.

Exclusion Criteria:

  • Pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
  • Patients chronically treated (i.e., two weeks or more) with any vasoactive medication (i.e., antihypertensive) or lipid lowering therapy.
  • Patients who started taking nonsteroidal anti-inflammatory drugs within two months prior to the baseline visit.
  • Diagnosis of uncontrolled metabolic diseases including diabetes, kidney, liver, or cardiovascular diseases.
  • Use of systemic antibiotics in the preceding 3 month.
  • Patients taking steroid medications except for acute topical treatment.
  • Patients with active infectious diseases such as hepatitis, HIV, or TB.
  • Patients who require antibiotic pre-medication for the performance of periodontal examination or treatment.
  • Patients who received a course of periodontal treatment within the last 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327561

Locations
United Kingdom
UCL Eastman Dental Institute and Hospital
London, United Kingdom, WC1X 8LD
UCL Vascular Biology Laboratory - Great Ormond Street Hospital
London, United Kingdom
Sponsors and Collaborators
Eastman Dental Insitute and Hospital
University College London Hospitals
British Heart Foundation
The European Research Group on Periodontology (ERGOPerio)
Johnson & Johnson
CORDA, The Heart Charity
The European Social Fund
Italian Society of Periodontology
Investigators
Principal Investigator: Maurizio Tonetti, DMD PhD University College London Hospitals and University of Connecticut Health Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00327561     History of Changes
Other Study ID Numbers: UCLH03/E007
Study First Received: May 16, 2006
Last Updated: May 16, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by Eastman Dental Insitute and Hospital:
Inflammation
Periodontitis
Endothelial function
Atherosclerosis
Controlled trial

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013