Status:
COMPLETED
Effect of Intensive Periodontal Therapy on Vascular Function
Lead Sponsor:
Eastman Dental Insitute and Hospital
Collaborating Sponsors:
University College London Hospitals
British Heart Foundation
Conditions:
Periodontitis
Eligibility:
All Genders
35-60 years
Phase:
PHASE3
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 o...
Detailed Description
In the last decade considerable evidence has supported the hypothesis that chronic low-grade infections, periodontitis included, and the inflammatory responses associated with them may play a signific...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00327561
Start Date
September 1 2003
End Date
March 1 2005
Last Update
May 18 2006
Active Locations (2)
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1
UCL Eastman Dental Institute and Hospital
London, United Kingdom, WC1X 8LD
2
UCL Vascular Biology Laboratory - Great Ormond Street Hospital
London, United Kingdom