Can dental treatment protect us from heart disease?
| ISRCTN | ISRCTN17035727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17035727 |
| Secondary identifying numbers | PAROII/2016 |
- Submission date
- 10/01/2018
- Registration date
- 12/01/2018
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Platelets are small blood cells that aggregate (bind) upon activation, which can cause thrombus formation and activation of the immune system. Thereby platelet activation leads to the initiation and progression of cardiovascular disease. As platelets are very sensitive even mild inflammatory stimuli can activate them. Recently we found that periodontitis (gum disease), a chronic inflammation of the gums and areas around the death, results in platelet activation. Periodontal disease has previously been associated with cardiovascular disease and platelet activation provides an important link. Therefore, the aim of this study is to investigate if periodontal treatment, the cleaning of the dental pockets to diminish inflammation, can prevent platelet activation.
Who can participate?
Adults aged 18 and older who have periodontal disease.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the periodontal treatment at the beginning of the study and provide blood samples before and after three months of treatment. Those in the second group are simple informed about dental hygiene and receive their treatment three months later after the study has finished.
What are the possible benefits and risks of participating?
Participants may benefit from the periodontal treatment for systemic disease like cardiovascular disease. As only little amounts of blood are needed the study bears no medical risk for the patients. Postponing periodontal treatment for 3 months, e.g. in the control group, should not put patients at risk either. In case they are in pain or suffer from any other dental complications, they will be excluded from the study and receive full dental treatment. Further we provide financial reimbursement for study participants.
Where is the study run from?
Medical University of Vienna (Austria)
When is the study starting and how long is it expected to run for?
October 2015 to October 2018
Who is funding the study?
Medical Scientific Fund of the Mayor of the City of Vienna (Austra)
Who is the main contact?
Professor Alice Assinger (Scientific)
Contact information
Scientific
CePP, Medical University of Vienna
Schwarzspanierstr 17
Vienna
1090
Austria
 ORCID ID |
0000-0002-5670-5910 |
|---|
Study information
| Study design | Randomised controlled intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17035727_PIS_12Jan18.pdf |
| Scientific title | Does periodontal treatment prevent platelet activation in patients with periodontitis? A controlled therapeutic trial |
| Study acronym | TreatPP |
| Study objectives | Immediately after treatment, platelet activation would be increased, while patients might gain long-term (cardio)vascular benefits from the periodontal treatment. The results of this study are supposed to add significant knowledge to a comprehensive view of the systemic consequences of periodontal disease. |
| Ethics approval(s) | Ethical commission of the Medical University of Vienna, 02/09/2014, ref: 1656/2014 |
| Health condition(s) or problem(s) studied | Periodontitis |
| Intervention | Eligible patients undergo baseline anamnesis of periodontal disease, microbiological assessment (PCR, 11 putative periodontal pathogens) and blood testing and full medical and dental histories were collected. Then patients are randomly assigned to receive intensive periodontal treatment (treatment group) or community-based periodontal care (control group). Patients of the control group receive community based periodontal care. Their intensive periodontal takes place three months after diagnosis, i.e. after their study participation. Intensive periodontal treatment is performed by subgingival debridement with curettes and sonic instruments generally in two to four treatment sessions after the initial examination. Each session of subgingival debridement lasted for 1-2 hours with an interval of one week between treatment appointments. At the beginning of each appointment a simplified plaque score is recorded and appropriate individualized oral hygiene instructions are given. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Platelet P-selectin surface expression is measured using whole blood from patients and laboratory analysis via flow cytometry before and immediately after treatment and 3 months after. |
| Secondary outcome measures | Platelet aggregation is measured using whole blood from patients and laboratory analysis via light transmission aggregometry before and immediately after treatment and 3 months after. |
| Overall study start date | 01/10/2015 |
| Completion date | 01/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 52 |
| Key inclusion criteria | 1. Understanding of the study requirements 2. At least one interproximal site with a probing depth ≥ 5 mm and a loss of attachment at ≥ 2 interproximal sites ≥ 5 mm 3. Ages 18 and older |
| Key exclusion criteria | 1. Systemic diseases including diabetes mellitus 2. Chronic renal failure or liver cirrhosis 3. Systemic antibiotic treatment in the preceding 3 months 4. Periodontal treatment within the last 4 months 5. Pregnancy or breast feeding 6. Medication which affects platelets |
| Date of first enrolment | 01/11/2015 |
| Date of final enrolment | 01/06/2016 |
Locations
Countries of recruitment
- Austria
Study participating centre
School of Dentistry
Vienna
1090
Austria
Sponsor information
Government
Otto Wagner Platz 3
Vienna
1090
Austria
"ROR" |
https://ror.org/00nkcmy90 |
|---|
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal within 2 years of study end date. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from markus.laky@meduniwien.ac.at |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 12/01/2018 | 01/04/2019 | No | Yes | |
| Results article | results | 01/09/2018 | 23/11/2020 | Yes | No |
| Results article | 29/08/2019 | 27/02/2023 | Yes | No |
Additional files
- ISRCTN17035727_PIS_12Jan18.pdf
- Uploaded 01/04/2019
Editorial Notes
27/02/2023: Publication reference added.
23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
01/04/2019: The participant information sheet has been uploaded.
