Effect of Intensive Periodontal Therapy on Vascular Function

NCT00327561 | Completed Phase 3

• 1 other identifier: UCLH03/E007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontitis

Keywords

Inflammation; Periodontitis; Endothelial function; Atherosclerosis; Controlled trial

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilatation of the brachial artery

Secondary Outcomes (1)

• Serum inflammatory and endothelial function markers

Interventions

Intensive periodontal therapy PROCEDURE

Community based periodontal therapy PROCEDURE

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• pockets with a PD of \> 5 must bleed on probing.
• Absence of other significant oral infections.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastman Dental Insitute and Hospital: lead
• University College London Hospitals: collaborator
• British Heart Foundation: collaborator
• The European Research Group on Periodontology (ERGOPerio): collaborator
• Johnson & Johnson: collaborator
• CORDA, The Heart Charity: collaborator
• European Social Fund: collaborator
• Italian Society of Periodontology: collaborator

Study Sites (2)

UCL Eastman Dental Institute and Hospital

London, WC1X 8LD, United Kingdom

Location

UCL Vascular Biology Laboratory - Great Ormond Street Hospital

London, United Kingdom

Location

Related Publications (7)

• 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. doi: 10.1016/j.ahj.2005.06.018.

  PMID: 16644317 BACKGROUND

• 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. doi: 10.1177/154405910508400312.

  PMID: 15723869 BACKGROUND

• 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. doi: 10.1177/154405910408300214.

  PMID: 14742655 BACKGROUND

• D'Aiuto F, Tonetti MS. Contribution of periodontal therapy on individual cardiovascular risk assessment. Arch Intern Med. 2005 Sep 12;165(16):1920-1. doi: 10.1001/archinte.165.16.1920. No abstract available.

  PMID: 16157839 BACKGROUND

• 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. doi: 10.1016/j.cyto.2004.06.005.

  PMID: 15341923 BACKGROUND

• D'Aiuto F, Parkar M, Tonetti MS. Periodontal therapy: a novel acute inflammatory model. Inflamm Res. 2005 Oct;54(10):412-4. doi: 10.1007/s00011-005-1375-4.

  PMID: 16283108 BACKGROUND

• 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. doi: 10.1111/j.1600-051X.2004.00580.x.

  PMID: 15086624 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Inflammation; Atherosclerosis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maurizio Tonetti, DMD PhD

  University College London Hospitals and University of Connecticut Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 18, 2006
• Study Start: September 1, 2003
• Study Completion: March 1, 2005
• Last Updated: May 18, 2006

Record last verified: 2005-03

Locations

GB (2)