Condition category
Oral Health
Date applied
10/11/2020
Date assigned
11/11/2020
Last edited
11/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Tooth cavities can be diagnosed with different methods, including visual/tactile inspection followed by bitewing and/or periapical radiographs (x-rays), as well as transillumination (light) devices. Although cavities in the front teeth or on the chewing surface of the back teeth can be easily identified by clinical inspection, this procedure fails to detect developing cavities on the surfaces between adjacent teeth. Therefore, supporting diagnostic techniques need to be tested. The aim of this study is to evaluate the accuracy and the time required for a digital imaging fiber-optic transillumination (DIFOTI) device to detect cavities compared to oral examination and bitewing radiographs.

Who can participate?
Patients aged 12-35

What does the study involve?
Participants undergo a clinical inspection and bitewing radiographs are taken by two independent examiners. A third investigator will take digital images of the teeth using a DIFOTI device. The time required for carrying out both procedures will be measured.

What are the possible benefits and risks of participating?
Possible benefits of participating will be reduced x-ray exposure and detection of cavities.

Where is the study run from?
1. University of Bologna (Italy)
2. University of Campinas (Brazil)

When is the study starting and how long is it expected to run for?
October 2018 to January 2021

Who is funding the study?
University of Bologna (Italy)

Who is the main contact?
Prof. Gian Andrea Pelliccioni
gian.pelliccioni@unibo.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gianandrea Pelliccioni

ORCID ID

Contact details

Department of Biomedical and Neuromotor Sciences
Alma Mater Studiorum
University of Bologna
Bologna
40125
Italy
+39 (0)512088111
gian.pelliccioni@unibo.it

Type

Public

Additional contact

Prof Gianandrea Pelliccioni

ORCID ID

Contact details

Department of Biomedical and Neuromotor Sciences
Alma Mater Studiorum
University of Bologna
Bologna
40125
Italy
+39 (0)512088111
gian.pelliccioni@unibo.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CE AVEC 699/2018/OSS/AUSLBO

Study information

Scientific title

Clinical analysis of the diagnostic accuracy and time of execution of a transillumination caries detection method compared to bitewing radiographs

Acronym

Study hypothesis

1. The use of a transillumination device is as accurate as traditional diagnostic methods for the detection of approximal carious lesions
2. The DIFOTI-based device requires significantly less time to perform the examination process

Ethics approval

Approved 14/11/2018, Ethical Committee Bologna-Imola (29 Castiglione Street, 40124 Bologna, Italy; +39 (0)51 6225111; corrado.iacono@ausl.bologna.it), ref: 18106-18130\2018

Study design

Cross-sectional single-center study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dental caries

Intervention

Clinical exams will be performed by using an intra-oral mirror and a dental explorer on all teeth of each patient, followed by digital bitewing radiographs (CS 7600 scanner, Carestream Dental, LLC, Atlanta, GA, USA). All diagnostic data collected during anamnesis and clinical/radiographic exams will be interpreted and converted into ICDAS scores, being then registered on electronic forms. Afterwards, a trained dental hygienist, blinded to the results of the initial examination, will reassess the patients with a DIFOTI-based device (DIAGNOcamTM, KaVo Dental, Genova, GE, Italy). Transillumination images will be obtained by placing the device parallel to the occlusal surfaces of the teeth. DIFOTI data will be also converted into ICDAS scores and added to the electronic forms. Moreover, the time necessary to execute either bitewing radiographs or DIFOTI images will be registered for comparison between the techniques.

Intervention type

Device

Phase

Not Applicable

Drug names

CS 7600 scanner (Carestream Dental, LLC, Atlanta, GA, USA), DIFOTI-based device (DIAGNOcamTM, KaVo Dental, Genova, GE, Italy)

Primary outcome measure

1. Radiographs (CS 7600 scanner, Carestream Dental, LLC, Atlanta, GA, USA) examined according to the O’Mullane criteria and the presence or absence of carious lesions recorded by the O’Mullane criteria fitted into the ICDAS classification at a single timepoint
2. Approximal carious lesions detected by a transillumination device (DIAGNOcamTM, KaVo Dental, Genova, GE, Italy) according to criteria adapted from Lara-Capi et al. (2017), translated into the ICDAS score, at a single timepoint

Secondary outcome measures

The time required for taking bitewing radiographs and acquiring DIFOTI images, recorded by a digital chronometer at a single timepoint

Overall trial start date

14/10/2018

Overall trial end date

15/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 12-35
2. American Society of Anesthesiologists Classification (ASA I - normal healthy) patients

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

110 patients

Participant exclusion criteria

1. Presence of total dentures
2. Presence of fixed orthodontic appliances

Recruitment start date

15/11/2020

Recruitment end date

15/01/2021

Locations

Countries of recruitment

Brazil, Italy

Trial participating centre

University of Bologna
Department of Biomedical and Neuromotor Sciences Alma Mater Studiorum Via San Vitale, 59
Bologna
40125
Italy

Trial participating centre

University of Campinas
Department of Restorative Dentisty Operative Dentistry Division Piracicaba Dental School Avenida Limeira, 901 Piracicaba, SP
Campinas
13414-903
Brazil

Sponsor information

Organisation

University of Bologna

Sponsor details

Via Zamboni 33
Bologna
40125
Italy
+39 (0)512099111
scriviunibo@pec.unibo.it

Sponsor type

University/education

Website

http://www.unibo.it/en/homepage

Funders

Funder type

University/education

Funder name

Università di Bologna

Alternative name(s)

University of Bologna, UNIBO

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Italy

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 are/will be available upon request from Prof. Gian Andrea Pelliccioni (gian.pelliccioni@unibo.it) from the publication of the results for 1 year.

Intention to publish date

01/07/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2020: Trial's existence confirmed by the Ethical Committee Bologna-Imola.