Comparison between a radiological method (bitewing radiographs) and a method based on digital imaging fiber-optic transillumination (DIFOTI) for caries detection
| ISRCTN | ISRCTN12315324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12315324 |
| Secondary identifying numbers | CE AVEC 699/2018/OSS/AUSLBO |
- Submission date
- 10/11/2020
- Registration date
- 11/11/2020
- Last edited
- 06/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Department of Biomedical and Neuromotor Sciences
Alma Mater Studiorum
University of Bologna
Bologna
40125
Italy
| Phone | +39 (0)512088111 |
|---|---|
| gian.pelliccioni@unibo.it |
Public
Department of Biomedical and Neuromotor Sciences
Alma Mater Studiorum
University of Bologna
Bologna
40125
Italy
| Phone | +39 (0)512088111 |
|---|---|
| gian.pelliccioni@unibo.it |
Study information
| Study design | Cross-sectional single-center study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical analysis of the diagnostic accuracy and time of execution of a transillumination caries detection method compared to bitewing radiographs |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 14/10/2018 |
| Completion date | 15/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 110 patients |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 12-35 2. American Society of Anesthesiologists Classification (ASA I - normal healthy) patients |
| Key exclusion criteria | 1. Presence of total dentures 2. Presence of fixed orthodontic appliances |
| Date of first enrolment | 15/11/2020 |
| Date of final enrolment | 15/01/2021 |
Locations
Countries of recruitment
- Brazil
- Italy
Study participating centres
Alma Mater Studiorum
Via San Vitale, 59
Bologna
40125
Italy
Operative Dentistry Division
Piracicaba Dental School
Avenida Limeira, 901
Piracicaba, SP
Campinas
13414-903
Brazil
Sponsor information
University/education
Via Zamboni 33
Bologna
40125
Italy
| Phone | +39 (0)512099111 |
|---|---|
| scriviunibo@pec.unibo.it | |
| Website | http://www.unibo.it/en/homepage |
"ROR" |
https://ror.org/01111rn36 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Bologna, UNIBO
- Location
- Italy
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/10/2021 | 06/01/2022 | Yes | No |
Editorial Notes
06/01/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
11/11/2020: Trial's existence confirmed by the Ethical Committee Bologna-Imola.
