A Randomized, Controlled Trial to Study Effects of Periodontal Therapy in Primary Prevention of Cardiovascular Disease.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)