Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081976
• Other study ID #: Mac/Saibliss 2120
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2014
• Last updated: March 6, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Macmillan Research Group UK
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Periodontitis

Intervention

Behavioral:
• Integrated Care Group
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.

Other:
• Standard Care Group
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.

Locations

Country	Name	City	State
India	GyanSanjeevani	Jaipur	Rajasthan

Sponsors (2)

Lead Sponsor	Collaborator
Macmillan Research Group UK	Saibliss Healthcare Vision

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Pressure and Sugar		Change from baseline to six months	No
Primary	Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)		Change from baseline to six month	No
Secondary	High- and low-density lipoprotein cholesterol		Change from baseline to six month	No
Secondary	cardiovascular risk scores (Framingham)		Change from baseline to six months	No