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Effect of Intensive Periodontal Therapy on Vascular Function

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ClinicalTrials.gov Identifier: NCT00327561
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : May 18, 2006
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Periodontitis Procedure: Intensive periodontal therapy Procedure: Community based periodontal therapy Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Non-Surgical Periodontal Therapy on Endothelial Function A Randomized Controlled Clinical Trial
Study Start Date : September 2003
Estimated Study Completion Date : March 2005
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Flow mediated dilatation of the brachial artery

Secondary Outcome Measures :
  1. Serum inflammatory and endothelial function markers

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327561

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
European Social Fund
Italian Society of Periodontology
Principal Investigator: Maurizio Tonetti, DMD PhD University College London Hospitals and University of Connecticut Health Center
More Information

ClinicalTrials.gov Identifier: NCT00327561     History of Changes
Other Study ID Numbers: UCLH03/E007
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 18, 2006
Last Verified: March 2005

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

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases