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Periodontal DiseasePerio-CHDNCT01201746

Influence of Periodontal Treatment on Systemic Inflammatory Mediators

A study testing Delayed treatment and Periodontal therapy in people with Periodontal Disease and Coronary Heart Disease, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 31 years and older
Conditions the study is for
Periodontal Disease, Coronary Heart Disease
What is being tested?
Delayed treatment and Periodontal therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
317 participants
Where
1 sitePakistan
Study dates
Jul 2008to May 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 31 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • 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).

Who cannot join

  • 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.
Show all 23Show fewer
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Punjab Institute of Cardiology

    Lahore, Punjab Province, 54300

Other trials in Pakistan

About this study

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

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.

Being tested
Delayed treatment, Periodontal therapy
Keywords
Non-surgical periodontal therapy, Coronary heart disease (CHD), periodontal Disease, hsCRP, Fibrinogen, WBCs
Medical subject headings
Periodontal Diseases, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed treatmentProcedure or surgery

    Also called Control group

    Scaling, Root Planing and oral hygiene instruction

  • Periodontal therapyProcedure or surgery

    Also called Experimental group

    Scaling, root planning and oral hygiene instructions

Study groups in NCT01201746
Study groupRoleWhat they receive
Periodontal TherapyExperimentalScaling Root planing and oral hygiene instructions
Receives: Procedure: Periodontal therapy
Delayed treatmentPlacebo comparatorScaling Root planing and oral hygiene instructions
Receives: Procedure: Delayed treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. high-sensitivity C-Reactive Protein (hsCRP)

    Measured: 1-3 months

Secondary outcomes (2)

  1. Fibrinogen

    Measured: 1-3 months

  2. White Blood Cells

    Measured: 1-3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2010 (estimated)
  2. Study startJul 2008
  3. Primary completionApr 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01201746
Sponsor's protocol ID
PU-D/314/Acad
Other IDs
HEC-20-685/06
Acronym
Perio-CHD
Status last verified
Sep 2010
First submitted
13 Sep 2010
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Delayed treatment and Periodontal therapy in people with Periodontal Disease and Coronary Heart Disease, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

high-sensitivity C-Reactive Protein (hsCRP) (time frame: 1-3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01201746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.

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