Condition category
Oral Health
Date applied
13/01/2020
Date assigned
31/01/2020
Last edited
05/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Periodontitis is often known as 'Gum Disease' and is a very common condition in which the gums and deeper periodontal structures become inflamed.
In a previous project from our research group, a self-reported oral health questionnaire to screen for periodontitis was validated a rapid and non-invasive screening tool for periodontitis was developed. The tool is eventually to be used in medical settings where oral examinations for periodontitis are not feasible. Before this screening tool can be implemented on a large scale, it also requires external validation. In other words, we need to assess its performance in a medical patient population other than the one used for the development. Once externally validated against a routine clinical periodontitis screening, our screening tool could support, for example, diabetes care providers to screen fort periodontitis and with that to adhere to the medical guidelines and recommendations without the need of an oral examination.
The main objective of this study is to externally validate a screening tool for periodontitis, based on a self-reported oral health questionnaire and patient demographics (sex, age, smoking, ethnicity, education level, number of yearly dental visits).

Who can participate?
Patients aged 18 – 80 years, with at least one of their own teeth

What does the study involve?
Patients will be examined using the new screening tool and the standard method when they attend clinic.

What are the possible benefits and risks of participating?
It is likely that there will be no noticeable advantages for the patients. However, it is possible that the routine oral examination (the screening for periodontitis) reveals periodontal problems that had been unnoticed until that point. If so, the patient is immediately notified, and it is recommended to visit his/her dentist. If this results in early diagnosis and treatment of periodontitis by the dentist, this will have positive effects on oral health and possible also systemic health of the patient.

All oral examinations and measurements are non-invasive and fast (The Dutch Periodontal Screening index, 5 minutes); there are no risks for the patient, except perhaps in some situations there will be a short-lived discomfort. The DPSI measurements take place during the already planned appointment at the outpatient internal medicine policlinic (UMC, location AMC). Other than the additional time that is required for this study (approximately 3 minutes for filling in the questionnaire and 5 mins for the DPSI), there are no disadvantages for participating in the study.

Where is the study run from?
UMC, location AMC Amsterdam, The Netherlands

When is the study starting and how long is it expected to run for?
September 2019 to March 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof B.G. Loos
b.loos@acta.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof B.G. Loos

ORCID ID

http://orcid.org/0000-0002-8794-552X

Contact details

ACTA (Academic Center of Dentistry Amsterdam)
Departement of Periodontology:
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
+31 20 5980322
b.loos@acta.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019.267

Study information

Scientific title

Validation of a questionnaire for rapid, non-invasive screening of periodontitis in a medical care setting

Acronym

PERIOSCREEN

Study hypothesis

The primary purpose of this present study was to perform an external validation of the rapid non-invasive screening tool for periodontitis as developed by Verhulst et al. (2019). It will be investigated whether this screening tool model is valid outside the ACTA clinics.

Ethics approval

Approved 12/07/2019, Medical Ethical Committee of the UMC, location VU Medical Center (VUmc) (BS7, room H-443, Postbus 7057, 1007 MB Amsterdam; +31 20 44 45585; metc@vumc.nl), ref: 2019.267

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Periodontitis

Intervention

Within one week before a clinical visit to a medical doctor (internist, outpatient internal medicine clinics UMC (University Medical Center), location AMC (Academic Medical Center) Amsterdam), all planned patients will receive an information letter about the current ongoing study. When waiting in the waiting room, researcher 1 will ask the patient to participate. If the patient approves to participate, he/she is taken into the research room.

First researcher 1, the SROH (Self-Reported Oral Health) questionnaire is conducted, which will take about 3 minutes.

Second, researcher 2 performs the periodontal examination (periodontitis screening by the Dutch Periodontal Screening Index [DPSI]) and informs the patient about whether he/she is suspected to have periodontitis (DPSI category C); the periodontal examination will take about 5 minutes. Therefore the research will take 8 minutes total.

Finally, the remaining data of the GH questionnaire such as BMI, blood pressure, HbA1c, LDL-, HDL- and total cholesterol level, triglycerides, eGFR, albumin and creatinine concentration, medication and diseases are obtained through EPIC, the electronic health record of the UMC.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. DPSI (measured by one of the researchers): periodontitis yes/no
2. SROH questionnaire (done by one of the researchers and calculated by a formula): suspected to have periodontitis yes/no’
3. Model performance parameters: sensitivity, specificity, NPV, PPV and AURROC

Secondary outcome measures

Obtained through EPIC, the electronic health record of the UMC:
1. BMI (kg/m²)
2. Blood pressure (mmHg)
3. HbA1c, LDL-, HDL- and total cholesterol level
4. Triglycerides
5. eGFR
6. Albumin and creatinine concentration
7. Demographic factors (age, ethnicity and education level)

Overall trial start date

01/01/2019

Overall trial end date

01/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients from 18 - 80 years of age
2. All ethnicities
3. All sexes
4. All education levels
5. At least one of their own teeth
6. Patients under control to an internist at the internal medicine clinic (UMC, location AMC)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Edentulous (with or without full dentures (regardless of dental implant support)
2. Do not speak Dutch or English
3. Patients who were not present in EPIC (the electronic health record of the UMC)

Recruitment start date

01/09/2019

Recruitment end date

01/04/2020

Locations

Countries of recruitment

Netherlands

Trial participating centre

UMC location AMC Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Center for Dentistry Amsterdam

Sponsor details

Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
+31 20 598 0380
info@acta.nl

Sponsor type

Hospital/treatment centre

Website

https://www.acta.nl/nl/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

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.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository (Figshare). The data will be offered upon request to Prof. dr. B.G. Loos. Email: b.loos@acta.nl. Type of data: SPSS data file. Data is available from: after successful publication in a peer-reviewed journal for 10 years. Access criteria: academic researchers and joined publications. Patients did sign informed consent. Data is anonymous and can only be connected to the participant by the main investigators.

Intention to publish date

01/09/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/02/2020: Uploaded protocol (not peer reviewed) as an additional file. 22/01/2020: Trial’s existence confirmed by Medical Ethical Committee of the UMC, Amsterdam.