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Completed

NCT Number: NCT01201746

Influence of Periodontal Treatment on Systemic Inflammatory Mediators

Currently the research issue in establishing the role of periodontal disease (PD) in coronary heart disease (CHD) risk is to define the pathways that lead to cause-effect relationship between PD and CHD. There is no consensus on definition of a periodontal disease case or the threshold level that may give clear indication for this relationship. Periodontal therapy has been used in different studies with the hope that a change in periodontal disease status may modify the factors associated with CHD risk. Many of these studies, on role of periodontal therapy in the reduction of CHD associated risk-factors, were based on small study samples, and very few studies were randomized controlled trials. So a need for large prospective studies is warranted in literature.----------- A single-blind parallel-arm randomized controlled clinical trial was designed to observe the influence of periodontal treatment on serum inflammatory mediators of hsC-reactive protein, white blood cells and fibrinogen in CHD patients.

Hypothesis: Periodontal therapy in CHD patients, by reducing periodontal inflammation, may decrease the host systemic inflammatory burden associated with atherogenic processes.

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Key information

Age range

31 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Punjab Institute of Cardiology

Lahore, Punjab Province, 54300, Pakistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

A. General/Medical

  • Any race/ethnic group
  • Aged > 30 years
  • Male or female
  • CHD case (CHD angiographically confirmed)
  • CHD diagnosed > 3 months prior to entry into study.
  • No acute or chronic systemic conditions (see exclusion criteria below)
  • No medications/medication history that can interfere with the study (see exclusion criteria below)
  • Non-smoker (=Never smoker) or former smoker (=Does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months)
  • Able and willing to comply with study procedures
  • Able and willing to be available for the duration of the study
  • Able and willing to provide signed informed consent

B. Oral/Periodontal

  • Dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.
  • Baseline whole mouth BOP > 20% of sites.
  • Periodontitis case; periodontitis case defined as subject having ≥ 4 teeth with ≥ 1 site with PPD ≥ 4 mm & CAL ≥ 3 mm at same site
  • No mechanical periodontal therapy in the last 6 months.
  • No acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., NUG).

Exclusion criteria

A. General/Medical

  • Age ≤ 30 years
  • Not fulfilling criteria of defined CHD case
  • Fulfilling criteria of defined CHD case, but diagnosed ≤ 3 months prior to start of study
  • Current smoker
  • Former smoker who does not smoke but who has smoked ≥ 1 cigarette (or equivalent, in form of water pipe, pipe, cigar) in the last 12 months.
  • Females pregnant or lactating
  • Systemic chronic conditions known to be associated with periodontitis or with changes in systemic inflammation: Diabetes,Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.)
  • Systemic acute conditions known to affect systemic markers of inflammation: Acute bacterial infection, Acute viral infection (common cold, influenza, sinusitis), Orthopedic trauma, Surgery
  • Medications known to affect systemic inflammatory biomarkers: Statins, Systemic steroids, Non-steroidal anti-inflammatory drugs, Immunosuppressants,
  • Medications potentially affecting systemic inflammatory markers, if therapy started less than 3 months prior to study such as Hormone replacement therapy, Contraceptives
  • Systemic antibiotic therapy in the last 3 months
  • Unable or unwilling to comply with study procedures
  • Unable or unwilling to be available for the duration of the study
  • Unable or unwilling to provide signed informed consent

B. Oral/Periodontal

  • <14 teeth that can be periodontally evaluated (excluding 3rd molars)
  • BOP ≤ 20% of sites
  • Not fulfilling criteria of defined periodontitis case
  • Having received any periodontal therapy within last 6 months
  • Topical/local antibiotic or anti-inflammatory therapy in last 6 months
  • Acute oral infections
  • Oral wounds, including recent (< 2 months) extractions

Treatment and study plan

Delayed treatment

Procedure

Scaling, Root Planing and oral hygiene instruction

Other names: Control group

periodontal therapy

Procedure

Scaling, root planning and oral hygiene instructions

Other names: Experimental group

Primary outcomes

  1. high-sensitivity C-Reactive Protein (hsCRP)

    Time frame: 1-3 months

Secondary outcomes

  1. Fibrinogen

    Time frame: 1-3 months

  2. White Blood Cells

    Time frame: 1-3 months

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Other

Collaborators

  • Higher Education Commission (Pakistan)

Registry information

Official study title

Influence of Periodontal Treatment on Systemic Inflammatory Mediators:hsC-reactive Protein, Fibrinogen and White Blood Cells in CHD Patients

Acronym: Perio-CHD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2010
Registry last updated
Oct 14, 2016

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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