Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

Phase 2

Completed

• Conditions: Periodontitis; Coronary Disease
• Interventions: Behavioral: Integrated Care Group; Other: Standard Care Group

• Registration Number: NCT02081976
• Lead Sponsor: Macmillan Research Group UK

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Status Verified: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Study First Posted: 2014-03-07
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Care Group	Integrated Care Group	a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor
Standard Care Group	Standard Care Group	Dental therapist providing standard periodontal treatment

Primary Outcome Measures

Name	Time	Method
Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)	Change from baseline to six month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GyanSanjeevani; 🇮🇳 Jaipur, Rajasthan, India