Effect of Intensive Periodontal Therapy on Vascular Function - Full Text View

Sponsors and Collaborators:	Eastman Dental Insitute and Hospital University College London Hospitals British Heart Foundation The European Research Group on Periodontology (ERGOPerio) The Periodontology Research Fund of the Eastman Dental Institute 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

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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)

The Periodontology Research Fund of the Eastman Dental Institute

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:

D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. Am Heart J. 2006 May;151(5):977-84.

D'Aiuto F, Nibali L, Parkar M, Suvan J, Tonetti MS. Short-term effects of intensive periodontal therapy on serum inflammatory markers and cholesterol. J Dent Res. 2005 Mar;84(3):269-73.

D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60.

D'Aiuto F, Tonetti MS. Contribution of periodontal therapy on individual cardiovascular risk assessment. Arch Intern Med. 2005 Sep 12;165(16):1920-1. No abstract available.

D'Aiuto F, Parkar M, Brett PM, Ready D, Tonetti MS. Gene polymorphisms in pro-inflammatory cytokines are associated with systemic inflammation in patients with severe periodontal infections. Cytokine. 2004 Oct 7;28(1):29-34.

D'Aiuto F, Parkar M, Tonetti MS. Periodontal therapy: a novel acute inflammatory model. Inflamm Res. 2005 Oct;54(10):412-4.

D'Aiuto F, Parkar M, Andreou G, Brett PM, Ready D, Tonetti MS. Periodontitis and atherogenesis: causal association or simple coincidence? J Clin Periodontol. 2004 May;31(5):402-11.

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

Keywords provided by Eastman Dental Insitute and Hospital:

Inflammation
Periodontitis
Endothelial function
Atherosclerosis
Controlled trial

Study placed in the following topic categories:

Mouth Diseases
Atherosclerosis
Periodontal Diseases

Periodontitis
Stomatognathic Diseases
Inflammation

Additional relevant MeSH terms:

Mouth Diseases
Periodontal Diseases
Periodontitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 01, 2009