Condition category
Circulatory System
Date applied
24/04/2015
Date assigned
23/11/2015
Last edited
29/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

www.ugr.es

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

Publication citations

Additional files

Editorial Notes

29/01/2016: The recuritment start date has been changed from 01/12/2015 to 01/02/2016. Additionally, the criteria "Insulin-dependent" has now been removed from the exclusion criteria (prior to recruitment start).