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Clinical Trials/NCT02081976
NCT02081976
Completed
Phase 2

A Randomized, Controlled Trial to Study Effects of Periodontal Therapy in Primary Prevention of Cardiovascular Disease.

Macmillan Research Group UK1 site in 1 country57 target enrollmentApril 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Macmillan Research Group UK
Enrollment
57
Locations
1
Primary Endpoint
Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity all over the world. In the last years, efforts have been made to define more effective therapeutic and preventive strategies.Periodontal diseases have been considered a probable risk factor for CVD with a great amount of evidence from observational studies. Although there are some interventional studies evaluating the systemic effects of periodontal therapy, there is little information regarding the impact of periodontal treatment on the prevention of cardiovascular events. To the best of our knowledge, there are no randomized controlled trials published to date assessing the effect of periodontal therapy in primary prevention of CVD.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Macmillan Research Group UK
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Individuals having at least 50% of their dentition with periodontal probing pocket depths N4 mm and
  • With documented radiographic alveolar bone loss were included

Exclusion Criteria

  • Known systemic diseases
  • History and/or presence of other infections
  • Systemic antibiotic treatment in the preceding 3 months
  • Treatment with any medication known to affect the serum level of inflammatory markers, lipids, or BP
  • Pregnant or lactating females
  • Allergy to tetracyclines

Outcomes

Primary Outcomes

Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)

Time Frame: Change from baseline to six month

Secondary Outcomes

  • High- and low-density lipoprotein cholesterol(Change from baseline to six month)
  • cardiovascular risk scores (Framingham)(Change from baseline to six months)

Study Sites (1)

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