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Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

Primary Purpose

Periodontitis, Coronary Disease

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Integrated Care Group

Standard Care Group

About this trial

This is an interventional prevention trial for Periodontitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

GyanSanjeevani

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care Group

Integrated Care Group

Arm Description

Dental therapist providing standard periodontal treatment

a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor

Outcomes

Primary Outcome Measures

Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)

Secondary Outcome Measures

High- and low-density lipoprotein cholesterol

cardiovascular risk scores (Framingham)

Full Information

NCT ID

NCT02081976

First Posted

March 6, 2014

Last Updated

March 6, 2014

Sponsor

Macmillan Research Group UK

Collaborators

Saibliss Healthcare Vision

1. Study Identification

Unique Protocol Identification Number

NCT02081976

Brief Title

Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Macmillan Research Group UK

Collaborators

Saibliss Healthcare Vision

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis, Coronary Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Care Group

Arm Type

Active Comparator

Arm Description

Dental therapist providing standard periodontal treatment

Arm Title

Integrated Care Group

Arm Type

Experimental

Arm Description

a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor

Intervention Type

Behavioral

Intervention Name(s)

Integrated Care Group

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard Care Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)

Time Frame

Change from baseline to six month

Secondary Outcome Measure Information:

Title

High- and low-density lipoprotein cholesterol

Time Frame

Change from baseline to six month

Title

cardiovascular risk scores (Framingham)

Time Frame

Change from baseline to six months

Other Pre-specified Outcome Measures:

Title

Blood Pressure and Sugar

Time Frame

Change from baseline to six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neelam Maheshwari, BDS

Organizational Affiliation

Maheshwari Dental Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neha Sharma, PhD

Organizational Affiliation

Macmillan Research Group

Official's Role

Study Director

Facility Information:

Facility Name

GyanSanjeevani

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302019

Country

India

12. IPD Sharing Statement

Learn more about this trial

Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

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