Status:
COMPLETED
Influence of Periodontal Treatment on Systemic Inflammatory Mediators
Lead Sponsor:
Sheikh Zayed Federal Postgraduate Medical Institute
Collaborating Sponsors:
Higher Education Commission (Pakistan)
Conditions:
Periodontal Disease
Coronary Heart Disease
Eligibility:
All Genders
31+ years
Phase:
NA
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 C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT01201746
Start Date
July 1 2008
End Date
May 1 2009
Last Update
October 14 2016
Active Locations (1)
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1
Punjab Institute of Cardiology
Lahore, Punjab Province, Pakistan, 54300