An overview of white blood cells' functioning in patients with periodontitis

ISRCTN ISRCTN15252886
DOI https://doi.org/10.1186/ISRCTN15252886
Secondary identifying numbers 2012-210#B2012406
Submission date
11/07/2017
Registration date
11/08/2017
Last edited
28/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Periodontitis is an inflammatory disease that occurs in the oral cavity (mouth) and affects the supportive tissues of the teeth. If the inflammation progresses, this can lead to severe bone destruction and tooth loss. In response to the accumulation of microorganisms (bacteria), white blood cells called polymorphonuclear neutrophils can enter the oral cavity from the blood stream and mix in the oral fluid. The specific role of these oral PMNs (oPMNs) in periodontitis is uncertain. The aim of this study is to compare the PMNs in the mouths of people with and without periodontitis.

Who can participate?
Patients with and without untreated periodontitis

What does the study involve?
Blood and oral rinse samples are collected from patients with untreated periodontitis and people without periodontitis to measure the amount of PMNs, their activation, cell death and the generation of oxygen free radicals.

What are the possible benefits and risks of participating?
This study gives insights into the functioning of the immune response within the mouths of people with periodontitis. No risks or symptoms are expected to occur due to participating in this study.

Where is the study run from?
Academic Centre for Dentistry Amsterdam (Netherlands)

When is the study starting and how long is it expected to run for?
October 2014 to May 2016

Who is funding the study?
University of Amsterdam (Netherlands)

Who is the main contact?
Mr Patrick Rijkschroeff

Contact information

Mr Patrick Rijkschroeff
Scientific

Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands

ORCiD logoORCID ID 0000-0002-3997-0878

Study information

Study designObservational case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleCharacterization of functional oral polymorphonuclear neutrophils in periodontitis patients: an observational case-control study
Study objectivesKnowledge about polymorphonuclear neutrophils (PMNs) in the oral cavity periodontitis is limited and controversies exist regarding their function and significance. The rationale of this study was to characterize the PMNs from the oral cavity of patients with untreated periodontitis and compare those to the same cells from healthy subjects without periodontitis, since most of the periodontitis research on PMNs has made use of blood as the source material. Additionally, the characteristics of the oral PMNs were compared to those of the circulatory PMNs.
Ethics approval(s)Medical Ethics Committee of the VU University Medical Center, 29/03/2013, ref: 2012-210#B2012406
Health condition(s) or problem(s) studiedPeriodontitis
InterventionVenous blood and oral rinse samples were obtained from 19 patients with untreated periodontitis and 16 control subjects without periodontitis for PMN isolation. Cell numbers were counted and apoptosis was analysed using propidium iodide labelling. Expression of cell activation markers CD11b, CD63, and CD66b was analysed using flow cytometry. Constitutive ROS generation was detected using dihydrorhodamine123. Additionally, ROS production in response to stimulation was evaluated in samples incubated with 10 µM phorbol myristate acetate (PMA) or Fusobacterium nucleatum.
Intervention typeOther
Primary outcome measureThe presence of PMNs in the oral cavity of periodontitis patients, measured using flow cytometry directly after sampling. All samples were analyzed using flow cytometry on the same day.
Secondary outcome measures1. Cell counts, measured using a Muse cell counting device
2. Cell membrane integrity, measured with flow cytometric analysis using propidium iodide staining
3. PMN expression markers of cell activation: CD11b, CD63, CD66b and corrected for non-specific binding of isotype control antibodies
4. Presence of constitutive oxygen radicals (ROS), detected using dihydrorhodamine 123
5. Presence of ROS in response to stimulation, determined in samples incubated with phorbol myristate acetate (PMA) or Fusobacterium nucleatum
All outcomes measured at a single timepoint
Overall study start date01/10/2014
Completion date01/05/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants15
Key inclusion criteria1. Patients with untreated periodontitis
2. The presence of bone loss on ≥ 1/3 of the root length on minimum 2 non-adjacent teeth on vertical bite-wing radiographs not older than 12 months
3. Aged 18 and over
Key exclusion criteria1. A history of pathologic conditions that are known to systemically affect PMN functionality (such as hematological disorders, diabetes mellitus, antibiotics use within the last 6 months, recent history of illness or fever, allergies, alcoholism and pregnancy)
2. Less than 20 teeth
3. Removable partial dentures
4. Night guards
5. Orthodontic banding
6. (Peri) oral piercings
7. Apparent oral lesions
Date of first enrolment20/10/2014
Date of final enrolment01/04/2016

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Centre for Dentistry Amsterdam (ACTA)
1081LA
Netherlands

Sponsor information

University of Amsterdam
University/education

Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands

Phone +31 (0)205 980 888
Email info@acta.nl
Website http://www.acta.nl/en/
ROR logo "ROR" https://ror.org/04dkp9463

Funders

Funder type

University/education

Universiteit van Amsterdam
Government organisation / Universities (academic only)
Alternative name(s)
University of Amsterdam, UvA
Location
Netherlands

Results and Publications

Intention to publish date21/09/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Elena A. Nicu (e.nicu@acta.nl).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/08/2018 Yes No

Editorial Notes

28/08/2018: Publication reference added.
24/08/2018: The intention to publish date was changed from 01/11/2017 to 21/09/2018.