Periodontitis Clinical Trial
Official title:
Effects of Non-Surgical Periodontal Therapy on Endothelial Function A Randomized Controlled Clinical Trial
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | UCL Eastman Dental Institute and Hospital | London | |
United Kingdom | UCL Vascular Biology Laboratory - Great Ormond Street Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Eastman Dental Insitute and Hospital | British Heart Foundation, CORDA, The Heart Charity, European Social Fund, Italian Society of Periodontology, Johnson & Johnson, The European Research Group on Periodontology (ERGOPerio), University College London Hospitals |
United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
D'Aiuto F, Parkar M, Tonetti MS. Periodontal therapy: a novel acute inflammatory model. Inflamm Res. 2005 Oct;54(10):412-4. — View Citation
D'Aiuto F, Tonetti MS. Contribution of periodontal therapy on individual cardiovascular risk assessment. Arch Intern Med. 2005 Sep 12;165(16):1920-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flow mediated dilatation of the brachial artery | |||
Secondary | Serum inflammatory and endothelial function markers |
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