Influence of Periodontal Treatment on Systemic Inflammatory Mediators (Perio-CHD)
Primary Purpose
Periodontal Disease, Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Delayed treatment
Periodontal therapy
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring Non-surgical periodontal therapy, Coronary heart disease (CHD), periodontal Disease, hsCRP, Fibrinogen, WBCs
Eligibility Criteria
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
Sites / Locations
- Punjab Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Periodontal Therapy
Delayed treatment
Arm Description
Scaling Root planing and oral hygiene instructions
Scaling Root planing and oral hygiene instructions
Outcomes
Primary Outcome Measures
high-sensitivity C-Reactive Protein (hsCRP)
Secondary Outcome Measures
Fibrinogen
White Blood Cells
Full Information
NCT ID
NCT01201746
First Posted
September 13, 2010
Last Updated
October 13, 2016
Sponsor
Sheikh Zayed Federal Postgraduate Medical Institute
Collaborators
Higher Education Commission (Pakistan)
1. Study Identification
Unique Protocol Identification Number
NCT01201746
Brief Title
Influence of Periodontal Treatment on Systemic Inflammatory Mediators
Acronym
Perio-CHD
Official Title
Influence of Periodontal Treatment on Systemic Inflammatory Mediators:hsC-reactive Protein, Fibrinogen and White Blood Cells in CHD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheikh Zayed Federal Postgraduate Medical Institute
Collaborators
Higher Education Commission (Pakistan)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Coronary Heart Disease
Keywords
Non-surgical periodontal therapy, Coronary heart disease (CHD), periodontal Disease, hsCRP, Fibrinogen, WBCs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
317 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontal Therapy
Arm Type
Experimental
Arm Description
Scaling Root planing and oral hygiene instructions
Arm Title
Delayed treatment
Arm Type
Placebo Comparator
Arm Description
Scaling Root planing and oral hygiene instructions
Intervention Type
Procedure
Intervention Name(s)
Delayed treatment
Other Intervention Name(s)
Control group
Intervention Description
Scaling, Root Planing and oral hygiene instruction
Intervention Type
Procedure
Intervention Name(s)
Periodontal therapy
Other Intervention Name(s)
Experimental group
Intervention Description
Scaling, root planning and oral hygiene instructions
Primary Outcome Measure Information:
Title
high-sensitivity C-Reactive Protein (hsCRP)
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
Fibrinogen
Time Frame
1-3 months
Title
White Blood Cells
Time Frame
1-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayyaz A Khan, Ph.D.
Organizational Affiliation
Sheikh Zayed Federal Postgraduate Medical Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Syed Akhtar H Bokhari, MCPS
Organizational Affiliation
Sheikh Zayed Federal Postgraduate Medical Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Azhar, MRCP
Organizational Affiliation
Punjab Institute of Cardiology
Official's Role
Study Chair
Facility Information:
Facility Name
Punjab Institute of Cardiology
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54300
Country
Pakistan
12. IPD Sharing Statement
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Influence of Periodontal Treatment on Systemic Inflammatory Mediators
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