Condition category
Oral Health
Date applied
10/01/2018
Date assigned
12/01/2018
Last edited
12/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alice Assinger

ORCID ID

http://orcid.org/0000-0002-5670-5910

Contact details

CePP
Medical University of Vienna
Schwarzspanierstr 17
Vienna
1090
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PAROII/2016

Study information

Scientific title

Does periodontal treatment prevent platelet activation in patients with periodontitis? A controlled therapeutic trial

Acronym

TreatPP

Study hypothesis

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

Ethical commission of the Medical University of Vienna, 02/09/2014, ref: 1656/2014

Study design

Randomised controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

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

Phase

Drug names

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 trial start date

01/10/2015

Overall trial end date

01/10/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/11/2015

Recruitment end date

01/06/2016

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Division of Conservative Dentistry and Periodontology School of Dentistry
Vienna
1090
Austria

Sponsor information

Organisation

Anniversary Fund of the Austrian National Bank

Sponsor details

Otto Wagner Platz 3
Vienna
1090
Austria

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Medical Scientific Fund of the Mayor of the City of Vienna

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Austrian Science Fund (FWF P-24978)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anniversary Fund of the Austrian National Bank (OeNB grant#15961)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal within 2 years of study end date.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from markus.laky@meduniwien.ac.at

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes