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Influence of Periodontal Treatment on Systemic Inflammatory Mediators

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01201746
Acronym
Perio-CHD
Enrollment
317
Registered
2010-09-15
Start date
2008-07-31
Completion date
2009-05-31
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Periodontal Disease

Keywords

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

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.

Interventions

Scaling, Root Planing and oral hygiene instruction

Scaling, root planning and oral hygiene instructions

Sponsors

Higher Education Commission (Pakistan)
CollaboratorOTHER
Sheikh Zayed Federal Postgraduate Medical Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
31 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A. General/Medical 1. Any race/ethnic group 2. Aged \> 30 years 3. Male or female 4. CHD case (CHD angiographically confirmed) 5. CHD diagnosed \> 3 months prior to entry into study. 6. No acute or chronic systemic conditions (see

Exclusion criteria

below) 7. No medications/medication history that can interfere with the study (see

Design outcomes

Primary

MeasureTime frame
high-sensitivity C-Reactive Protein (hsCRP)1-3 months

Secondary

MeasureTime frame
Fibrinogen1-3 months
White Blood Cells1-3 months

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026