Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis, Coronary Disease

Intervention / Treatment
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* Behavioral: Integrated Care Group
* Other: Standard Care Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care Group<br>Dental therapist providing standard periodontal treatment | Other: Standard Care Group<br>* The group (TG) comprising one session of supragingival scaling followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days.<br>|
| Experimental: Integrated Care Group<br>a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor | Behavioral: Integrated Care Group<br>* The group (TG) consisted of periodontal treatment comprising one session of supragingival scaling and personalized oral hygiene instructions, followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days. Individuals were be followed monthly during the first 6 months. In the follow-up sessions, professional plaque removal, oral hygiene instructions, cardiac support along with counseling reinforcement were be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides) |  | Change from baseline to six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High- and low-density lipoprotein cholesterol |  | Change from baseline to six month | 
| cardiovascular risk scores (Framingham) |  | Change from baseline to six months |