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NCT Number: NCT02081976

Periodontal Therapy in a 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.

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Key information

Conditions

Periodontitis Cardiovascular Diseases Coronary Disease Heart Diseases Mouth Diseases Myocardial Ischemia Periodontal Diseases Stomatognathic Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GyanSanjeevani

Jaipur, Rajasthan, 302019, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Care Group

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.

Standard Care Group

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.

Primary outcomes

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

    Time frame: Change from baseline to six month

Secondary outcomes

  1. High- and low-density lipoprotein cholesterol

    Time frame: Change from baseline to six month

  2. cardiovascular risk scores (Framingham)

    Time frame: Change from baseline to six months

Other outcomes

  1. Blood Pressure and Sugar

    Time frame: Change from baseline to six months

Sponsors and collaborators

Lead sponsor

Macmillan Research Group UK

Industry

Collaborators

  • Saibliss Healthcare Vision

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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