Influence of Periodontal Treatment on Systemic Inflammatory Mediators

NCT ID: NCT01201746

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Periodontal Therapy

Scaling Root planing and oral hygiene instructions

Group Type: EXPERIMENTAL

Periodontal therapy

Intervention Type: PROCEDURE

Scaling, root planning and oral hygiene instructions

Delayed treatment

Scaling Root planing and oral hygiene instructions

Group Type: PLACEBO_COMPARATOR

Delayed treatment

Intervention Type: PROCEDURE

Scaling, Root Planing and oral hygiene instruction

Interventions

Delayed treatment

Scaling, Root Planing and oral hygiene instruction

Intervention Type: PROCEDURE

Periodontal therapy

Scaling, root planning and oral hygiene instructions

Intervention Type: PROCEDURE

Other Intervention Names

Control group; Experimental group

Eligibility Criteria

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.

Exclusion Criteria

8. 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)

9. Able and willing to comply with study procedures

10. Able and willing to be available for the duration of the study

11. Able and willing to provide signed informed consent

B. Oral/Periodontal

1. Dentate with at least 14 natural teeth, excluding third molars, that can be evaluated periodontally.

2. Baseline whole mouth BOP > 20% of sites.

3. Periodontitis case; periodontitis case defined as subject having ≥ 4 teeth with ≥ 1 site with PPD ≥ 4 mm & CAL ≥ 3 mm at same site

4. No mechanical periodontal therapy in the last 6 months.

5. No acute oral diseases (mucosal lesions), oral infections, need for immediate dental/periodontal care (e.g., NUG).

A. General/Medical

1. Age ≤ 30 years

2. Not fulfilling criteria of defined CHD case

3. Fulfilling criteria of defined CHD case, but diagnosed ≤ 3 months prior to start of study

4. Current smoker

5. 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.

6. Females pregnant or lactating

7. 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.)

8. Systemic acute conditions known to affect systemic markers of inflammation: Acute bacterial infection, Acute viral infection (common cold, influenza, sinusitis), Orthopedic trauma, Surgery

9. Medications known to affect systemic inflammatory biomarkers: Statins, Systemic steroids, Non-steroidal anti-inflammatory drugs, Immunosuppressants,

10. Medications potentially affecting systemic inflammatory markers, if therapy started less than 3 months prior to study such as Hormone replacement therapy, Contraceptives

11. Systemic antibiotic therapy in the last 3 months

12. Unable or unwilling to comply with study procedures

13. Unable or unwilling to be available for the duration of the study

14. Unable or unwilling to provide signed informed consent

B. Oral/Periodontal

1. <14 teeth that can be periodontally evaluated (excluding 3rd molars)

2. BOP ≤ 20% of sites

3. Not fulfilling criteria of defined periodontitis case

4. Having received any periodontal therapy within last 6 months

5. Topical/local antibiotic or anti-inflammatory therapy in last 6 months

6. Acute oral infections

7. Oral wounds, including recent (< 2 months) extractions

• Minimum Eligible Age: 31 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Higher Education Commission (Pakistan)

OTHER

Sponsor Role: collaborator

Sheikh Zayed Federal Postgraduate Medical Institute

OTHER

Sponsor Role: lead

Responsible Party

Syed Akhtar Hussain Bokhari

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayyaz A Khan, Ph.D.

Role: STUDY_DIRECTOR

Sheikh Zayed Federal Postgraduate Medical Institute

Syed Akhtar H Bokhari, MCPS

Role: PRINCIPAL_INVESTIGATOR

Sheikh Zayed Federal Postgraduate Medical Institute

Mohammad Azhar, MRCP

Role: STUDY_CHAIR

Punjab Institute of Cardiology

Locations

Punjab Institute of Cardiology

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

HEC-20-685/06

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PU-D/314/Acad

Identifier Type: -

Identifier Source: org_study_id