Condition category
Oral Health
Date applied
03/01/2011
Date assigned
28/07/2011
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.kirkkonummi.fi/mies40

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 measures

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

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

http://www.helsinki.fi/university/

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

government non-federal

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/04/2017: Plain English summary added.