Plain English Summary
Background and study aims
Periodontal inflammation (gum disease) is a very common condition where the gums become swollen, sore or infected. Cardiovascular (heart) disease (CVD) has several risk factors such as male gender, high blood pressure, high blood cholesterol, obesity, lack of physical activity and smoking. One suggested additional risk factor is infection. Periodontitis infection may be linked to CVD. Patients with periodontitis have increased levels of CRP and fibrinogen. Periodontal treatment has shown to reduce CRP levels. Severe forms of periodontitis can result in systematic inflammation (affecting the whole body) with high blood levels of CRP. Studies have found that CRP levels can be used to predict the risk of heart disease. The aims of these studies are to assess the effects of health promotion interventions on gum health, and to study the effects of periodontal treatment on general health and heart disease risk.
Who can participate?
Men aged 35 to 45 with two or more CVD risk factors (overweight, regular smoking, high blood fat/cholesterol, high blood sugar, high blood pressure)
What does the study involve?
This is a series of two studies. In the first study, participants are randomly allocated to three groups. The first group attends a health information session about heart disease and diabetes with a nurse. The second group receives both health information from nurses and a group exercise course of 12 sessions. The third group receives the exercise course after the 1-year follow-up. Participants undergo periodontal examinations carried out by dental hygienists and receive instructions on oral hygiene. They are followed up after 12 months to assess their exercise activity and heart disease risk. In the second study, participants found to have poor gum health are selected and randomly allocated to one of two groups. Plaque samples are taken at the start of the study and at follow-up. Participants in one group receive a deep cleaning under the gums carried out by a dentist, have a periodontal examination carried out by a dental hygienist, and provide blood samples. Participants in the other group are treated 3 months later. Heart disease risk factors and periodontal health are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Helsinki (Finland)
When is the study starting and how long is it expected to run for?
June 2009 to June 2011
Who is funding the study?
University of Helsinki (Finland)
Who is the main contact?
Dr Helena Liira
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helena Liira
ORCID ID
Contact details
University of Helsinki
Kuninkaantie 4
Kirkkonummi
02400
Finland
+358 (0)50 577 1351
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Association of periodontal infection with cardiovascular risks
Acronym
EHP
Study hypothesis
Exercise is an effective method to control the cardiovascular risk in men. The challenge is to change the exercise habits of men. In this study we aim to modify the exercise habits by a exercise intervention in a group and by a health promotion intervention by a nurse. We hypothesize that the interventions have effect on the dental periodontal health of the men.
Ethics approval
The coordinating ethics committee at Helsinki University Hospital, 08/06/2009, ref: 4/13/03/00/09
Study design
Cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
http://www.kirkkonummi.fi/mies40. Patient information sheets will be available in Finnish and Swedish
Condition
Men's general health and dental periodontal health
Intervention
Participants will be randomised into one of three groups:
1. First a health promotion intervention of 1h by a nurse practitioner, followed by an exercise course of 12 sessions in a group of men
2. Health promotion intervention by a nurse practitioner of 1h. Cardiovascular and diabetes risks are assessed and the consultation focuses on perceived risk behaviour
3. The control group will receive the exercise intervention after one year
All groups are followed up after 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Exercise activity and general health indicators and periodontal health indicators
Secondary outcome measures
Use of health services
Overall trial start date
06/06/2009
Overall trial end date
06/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male
2. Age 35 - 45 years
3. At least two cardiovascular risk factors of the following:
3.1. BMI 27.0 - 34.0 Kg/m²
3.2. Waist circumference > 94 cm
3.3. Fasting glucose < 6,1 mmHg/l
3.4. Total plasma cholesterol >4 mmHg/l
3.5. LDL-cholesterol > 3,0 mmHg/l
3.6. Triglycerides >2,0 mmHg/l
3.7. Blood pressure < 140/90 mm Hg
3.8. Currently engaging in/taking all of the following:
3.8.1. Smoking
3.8.2. Cholesterol-lowering medication
3.8.3. Blood pressure-lowering medication
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
300
Participant exclusion criteria
1. Exercise more then 3 times per week
2. BMI >34 Kg/m²
3. Chronic conditions (alcoholism, unstable heart problem, severe mental problems)
Recruitment start date
06/06/2009
Recruitment end date
06/06/2011
Locations
Countries of recruitment
Finland
Trial participating centre
University of Helsinki
Kirkkonummi
02400
Finland
Sponsor information
Organisation
Universty of Helsinki (Finland)
Sponsor details
c/o Dr Helena Liira
Kuninkaantie 4
Kirkkonummi
02400
Finland
+358 (0)50 577 1351
helena.liira@helsinki.fi
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Helsingin Yliopisto
Alternative name(s)
University of Helsinki, Helsingfors Universitet
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Finland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list