Influence of Periodontal Treatment on Systemic Inflammatory Mediators

NCT01201746 | Completed DMC

• 2 other identifiers: PU-D/314/AcadHEC-20-685/06
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Disease; Coronary Heart Disease

Keywords

Non-surgical periodontal therapy; Coronary heart disease (CHD); periodontal Disease; hsCRP; Fibrinogen; WBCs

Outcome Measures

Primary Outcomes (1)

• high-sensitivity C-Reactive Protein (hsCRP)

  1-3 months

Secondary Outcomes (2)

• Fibrinogen

  1-3 months

• White Blood Cells

  1-3 months

Study Arms (2)

Periodontal Therapy

EXPERIMENTAL

Scaling Root planing and oral hygiene instructions

Procedure: Periodontal therapy

Delayed treatment

PLACEBO COMPARATOR

Scaling Root planing and oral hygiene instructions

Procedure: Delayed treatment

Interventions

Delayed treatment PROCEDURE

Scaling, Root Planing and oral hygiene instruction

Also known as: Control group

Delayed treatment

Periodontal therapy PROCEDURE

Scaling, root planning and oral hygiene instructions

Also known as: Experimental group

Periodontal Therapy

Eligibility Criteria

• Age: 31 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead
• Higher Education Commission (Pakistan): collaborator

Study Sites (1)

Punjab Institute of Cardiology

Lahore, Punjab Province, 54300, Pakistan

Location

MeSH Terms

Conditions

Periodontal Diseases; Coronary Disease

Interventions

Treatment Delay; Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Time-to-Treatment; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayyaz A Khan, Ph.D.

  Sheikh Zayed Federal Postgraduate Medical Institute

  STUDY DIRECTOR

• Syed Akhtar H Bokhari, MCPS

  Sheikh Zayed Federal Postgraduate Medical Institute

  PRINCIPAL INVESTIGATOR

• Mohammad Azhar, MRCP

  Punjab Institute of Cardiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 15, 2010
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 14, 2016

Record last verified: 2010-09

Locations

PA (1)