Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

March 6, 2014 updated by: Macmillan Research Group UK

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India, 302019
        • Gyansanjeevani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care Group
Dental therapist providing standard periodontal treatment
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.
Experimental: Integrated Care Group
a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Blood Pressure and Sugar
Time Frame: Change from baseline to six months
Change from baseline to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macmillan Research Group UK

Collaborators

Saibliss Healthcare Vision

Investigators

  • Principal Investigator: Neelam Maheshwari, BDS, Maheshwari Dental Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mac/Saibliss 2120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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