35-45 year old men at elevated cardiovascular risk: Effects of Health Promotion interventions on periodontal health (EHP)

ISRCTN ISRCTN19622667
DOI https://doi.org/10.1186/ISRCTN19622667
Secondary identifying numbers N/A
Submission date
03/01/2011
Registration date
28/07/2011
Last edited
20/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Helena Liira
Scientific

University of Helsinki
Kuninkaantie 4
Kirkkonummi
02400
Finland

Phone +358 (0)50 577 1351
Email abc@email.com

Study information

Study designCohort study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet http://www.kirkkonummi.fi/mies40. Patient information sheets will be available in Finnish and Swedish
Scientific titleAssociation of periodontal infection with cardiovascular risks
Study acronymEHP
Study objectivesExercise 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(s)The coordinating ethics committee at Helsinki University Hospital, 08/06/2009, ref: 4/13/03/00/09
Health condition(s) or problem(s) studiedMen's general health and dental periodontal health
InterventionParticipants 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 typeOther
Primary outcome measureExercise activity and general health indicators and periodontal health’ indicators
Secondary outcome measuresUse of health services
Overall study start date06/06/2009
Completion date06/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants300
Key inclusion criteria1. 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
Key exclusion criteria1. Exercise more then 3 times per week
2. BMI >34 Kg/m²
3. Chronic conditions (alcoholism, unstable heart problem, severe mental problems)
Date of first enrolment06/06/2009
Date of final enrolment06/06/2011

Locations

Countries of recruitment

  • Finland

Study participating centre

University of Helsinki
Kirkkonummi
02400
Finland

Sponsor information

Universty of Helsinki (Finland)
University/education

c/o Dr Helena Liira
Kuninkaantie 4
Kirkkonummi
02400
Finland

Phone +358 (0)50 577 1351
Email helena.liira@helsinki.fi
Website http://www.helsinki.fi/university/
ROR logo "ROR" https://ror.org/040af2s02

Funders

Funder type

University/education

Helsingin Yliopisto
Government organisation / Universities (academic only)
Alternative name(s)
University of Helsinki, Helsingfors Universitet, Universitas Helsingiensis, HY, UH
Location
Finland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

20/04/2017: Plain English summary added.