Periostin and periodontal disease as modifiers of atherosclerotic coronary artery disease
| ISRCTN | ISRCTN17884414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17884414 |
| Secondary identifying numbers | PerioAteroma-2015 |
- Submission date
- 24/04/2015
- Registration date
- 23/11/2015
- Last edited
- 20/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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 December 2018
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
Contact information
Public
Facultad de Odontología, Colegio Máximo, Campus Universitario de Cartuja
Granada
18071
Spain
 ORCID ID |
0000-0001-6222-1341 |
|---|
Study information
| Study design | Randomised open-blind controlled interventional single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Periostin and periodontal disease as modifiers of atherosclerotic coronary artery disease: a randomised controlled trial |
| Study objectives | Periodontal treatment improves systemic biomarkers of atherosclerotic coronary artery disease through a reduction of circulating levels of periostin. |
| Ethics approval(s) | Human Research Ethics Committee, University of Granada, 27/01/2015, ref: 937. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Serum markers of atherosclerotic coronary artery disease and periostin. |
| Secondary outcome measures | Associated signs and markers of atherosclerosis and periodontal status. |
| Overall study start date | 25/09/2014 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged 18-75 2. Diagnosed atherosclerotic coronary artery disease 3. Diagnosed chronic severe periodontal disease |
| Key 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. |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 30/06/2018 |
Locations
Countries of recruitment
- Spain
Study participating centres
University Campus of Cartuja (Colegio Máximo, Campus Universitario de Cartuja, S/N)
Granada
18071
Spain
Granada
18014
Spain
Sponsor information
University/education
Gran Vía nº 48 - 2º planta
Granada
18071
Spain
| Website | www.ugr.es |
|---|---|
"ROR" |
https://ror.org/04njjy449 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a peer-review journal, with presentation at relevant scientific/non-scientific meetings. |
| IPD sharing plan |
Editorial Notes
20/12/2017: The following changers were made:
1. The recruitment end date has been changed from 31/07/2016 to 30/06/2018.
2. Overall trial end date has been changed from 28/02/2017 to 31/12/2018.
3. Intention to publish date was changed from 01/06/2017 to 31/12/2019.
29/01/2016: The recruitment 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).
