Plain English Summary
Background and study aims
Atherosclerosis is a serious condition where arteries become clogged up with fatty substances known as plaques. Plaques make the arteries harden and narrow, which restricts blood flow and can cause damage to organs by stopping them from working properly. They can also lead to blood clots which can trigger a stroke or heart attack. Atherosclerosis is the stage before cardiovascular disease, and it does not usually have symptoms until it is advanced and a person’s blood circulation is already restricted or blocked. When it is diagnosed at this late stage it is termed cardiovascular disease. Recent studies have shown a link between complications arising from gum disease (periodontal disease) and serious conditions like atherosclerosis. There is some evidence to suggest that preventing gum disease by practicing good oral health, such as regularly brushing your teeth, may help reduce your risk of developing heart disease. Biomarkers (biological markers) are molecules that come from cells which can be found circulating in the blood. Periostin is a biomarker that has been linked to gum disease, among other conditions. The aim of this study is to see if levels of periostin in the blood of patients with atherosclerosis change after the patients receive treatment for gum disease.
Who can participate?
Adults diagnosed with atherosclerosis and gum disease.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) receive surgical dental treatment for gum disease. Those in group 2 (control group) receive non-surgical dental treatment (i.e. scaling and root planing). All participants have blood tests at baseline, then at follow-up 2 weeks, 1 month, 3 months and 6 months after treatment.
What are the possible benefits and risks of participating?
The results of this study will provide valuable information that could potentially improve treatment for atherosclerotic disease. Also, each participant in this study has free treatment of his/her periodontal disease. Furthermore, the follow-up visits are beneficial because they reinforce oral hygiene techniques.
Where is the study run from?
1. University of Granada (Spain)
2. University Hospital Virgen de las Nieves (Hospital Universitario Virgen de las Nieves) (Spain)
When is the study starting and how long is it expected to run for?
September 2014 to February 2017
Who is funding the study?
1. 7th Framework Programme, Co-funding of Regional, National, and International Programmes (COFUND) - Marie Curie Actions (Spain)
2. Government of Andalucia (Consejería Economía, Innovación, Ciencia y Empleo, Junta de Andalucia) (Spain)
Who is the main contact?
Dr M Padial-Molina
Trial website
Contact information
Type
Public
Primary contact
Dr Miguel Padial-Molina
ORCID ID
http://orcid.org/0000-0001-6222-1341
Contact details
Facultad de Odontología
Colegio Máximo
Campus Universitario de Cartuja
Granada
18071
Spain
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PerioAteroma-2015
Study information
Scientific title
Periostin and periodontal disease as modifiers of atherosclerotic coronary artery disease: a randomised controlled trial
Acronym
Study hypothesis
Periodontal treatment improves systemic biomarkers of atherosclerotic coronary artery disease through a reduction of circulating levels of periostin.
Ethics approval
Human Research Ethics Committee, University of Granada, 27/01/2015, ref: 937.
Study design
Randomised open-blind controlled interventional single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Periodontal and atherosclerotic coronary artery disease
Intervention
1. Intervention: surgical treatment of periodontal disease by periodontal pocket reduction (modified Widman flap) and bone surgery (to smooth shallow boney craters) if required.
2. Control: no treatment (oral maintenance by non-surgical therapy (scaling and root planing).
Both groups have follow-up at 2 weeks, 1 month, 3 months and 6 months post-intervention.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Serum markers of atherosclerotic coronary artery disease and periostin.
Secondary outcome measures
Associated signs and markers of atherosclerosis and periodontal status.
Overall trial start date
25/09/2014
Overall trial end date
28/02/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18-75
2. Diagnosed atherosclerotic coronary artery disease
3. Diagnosed chronic severe periodontal disease
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Coronary event less than 6 months before enrolment
2. Renal failure (creatinine>1.5mg/dL)
3. Uncontrolled liver or pulmonary disease
4. Malignant tumour
5. Autoimmune disease
6. Neurologic or psychiatric disorder
7. Uncontrolled diabetes mellitus (HbA1c >8)
8. Presence of infectious disease (aside from periodontal)
9. Antibiotic or periodontal therapy 3 months before start of study
10. Alcoholism or drug abuse
11. Total edentulism
12. Other ongoing oral condition (orthodontic treatment, caries, etc.)
13. Any other contraindication for treatment or unwilling or unable for any reason to provide informed consent and participate in study.
Exclusion criteria after enrolment:
1. Periodontal disease progression of more than 2mm at the 3 months re-evaluation, (re)infarction, cardiovascular (re)intervention, or death.
Recruitment start date
01/02/2016
Recruitment end date
31/07/2016
Locations
Countries of recruitment
Spain
Trial participating centre
University of Granada
School of Dentistry
University Campus of Cartuja (Colegio Máximo, Campus Universitario de Cartuja, S/N)
Granada
18071
Spain
Trial participating centre
University Hospital Virgen de las Nieves (Hospital Universitario Virgen de las Nieves)
Av. de las Fuerzas Armadas, 2
Granada
18014
Spain
Sponsor information
Organisation
University of Granada
Sponsor details
Gran Vía nº 48 - 2º planta
Granada
18071
Spain
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
7th Framework Programme, Co-funding of Regional, National, and International Programmes (COFUND) - Marie Curie Actions (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Government of Andalucia (Consejería Economía, Innovación, Ciencia y Empleo, Junta de Andalucia) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a peer-review journal, with presentation at relevant scientific/non-scientific meetings.
Intention to publish date
01/06/2017
Participant level data
Available on request
Results - basic reporting
Publication summary