Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

NCT ID: NCT02081976

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

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.

Detailed Description

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Conditions

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Periodontitis Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care Group

Dental therapist providing standard periodontal treatment

Group Type ACTIVE_COMPARATOR

Standard Care Group

Intervention Type OTHER

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.

Integrated Care Group

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

Group Type EXPERIMENTAL

Integrated Care Group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saibliss Healthcare Vision

UNKNOWN

Sponsor Role collaborator

Macmillan Research Group UK

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neelam Maheshwari, BDS

Role: PRINCIPAL_INVESTIGATOR

Maheshwari Dental Clinic

Neha Sharma, PhD

Role: STUDY_DIRECTOR

Macmillan Research Group

Locations

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GyanSanjeevani

Jaipur, Rajasthan, India

Site Status

Countries

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India

Other Identifiers

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Mac/Saibliss 2120

Identifier Type: -

Identifier Source: org_study_id

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