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
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