Plain English Summary
Background and study aims
This study aims to use cone beam computed tomography (CBCT) to examine bone quantity and quality in specific facial regions among individuals with different ages, sex, and craniofacial patterns. The study particularly focuses on areas where temporary anchorage devices (TADs) are commonly applied in orthodontic treatments. The main goal is to determine if the thickness of certain types of bone in these areas is enough to ensure stability for TADs.
Who can participate?
Participants must have undergone CBCT scans for orthodontic reasons and be between 18 and 50 years old. They should also be in good health.
What does the study involve?
All participants' CBCT scans will be analyzed using specialized software. Bone thickness and density will be measured in specific regions of the face and overall bone widths will also be recorded. This data will help to understand the suitability of different sites for TAD placement.
What are the possible benefits and risks of participating?
Since this is a retrospective study, there are no direct benefits or risks for participants.
Where is the study run from?
The study is being conducted at the Dental Clinic of the University of L'Aquila in Italy.
When is the study starting and how long is it expected to run for?
The study protocol was developed on December 1, 2022. Data collection will begin after approval from the regional ethics committee, with the study expected to conclude on December 1, 2024.
Who is funding the study?
The University of L'Aquila in Italy. There is no external funding for this study.
Who is the main contact?
The main contact person for this study is Dr Simone Ettore Salvati, reachable at simoneettore.salvati@graduate.univaq.it
Study website
Contact information
Type
Public, Scientific, Principal Investigator
Contact name
Dr Simone Ettore Salvati
ORCID ID
http://orcid.org/0000-0001-9951-8595
Contact details
Via G. Petrini
L'Aquila
67100
Italy
+393804147033
simoneettore.salvati@graduate.univaq.it
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
PROTO-2022-12 Rev.6
Study information
Scientific title
Non-alveolar vestibular bone sites for temporary anchorage devices in orthodontics: a quantitative and qualitative analysis
Acronym
NAVBS-TAD-O-QQAD
Study hypothesis
The rationale for conducting this study lies in the need to comprehensively evaluate the bone quantity and quality in the alveolar bone regions where temporary anchorage devices (TADs) are commonly applied in orthodontic treatment. By utilizing cone beam computed tomography (CBCT) scanning, this research aims to investigate cortical bone thickness and cancellous bone density in the interradicular zones (IZC) and mandibular buccal shelf (MBS) across individuals with diverse demographic and craniofacial characteristics. The primary hypothesis is that cortical bone thickness exceeding 1 mm in the IZC and MBS regions will be adequate to ensure optimal primary stability for TAD placement. Additionally, it is hypothesized that higher cancellous bone density in these regions will further enhance the stability of TADs. Furthermore, this study intends to document overall bone widths to provide insights into the selection of appropriate TAD lengths for different anatomical sites. Overall, this investigation aims to contribute valuable data to the understanding of bone dynamics relevant to orthodontic treatment planning and TAD utilization.
Ethics approval(s)
Not yet submitted 22/02/2024, Territorial Ethics Committee Abruzzo Region (C.Et.R.A.) (Not provided, L'Aquila, 67100, Italy; Not provided; cer@regione.abruzzo.it), ref: Not provided
Study design
Single-centre retrospective cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Study setting(s)
University/medical school/dental school
Study type
Efficacy
Patient information sheet
Condition
Evaluation of bone characteristics for orthodontic mini-implant placement in select patients
Intervention
Cone beam computed tomography (CBCT) scanning records will be processed and analyzed using the open-source medical image processing platform, 3D Slicer v 5.4.0. To ensure compatibility with lateral skull teleradiography, 2D images will be derived from each CBCT scan through lateral radiographic projection. The resulting reconstructed lateral cephalograms (RLCs) will be assessed using the web-based digital cephalometric analysis program, WebCeph version 1.5.0, to define craniofacial patterns, with a focus on Facial Height Ratio (FHR) or Jarabak's quotient. Reslicing the DICOM dataset will be performed to enhance anatomical symmetry and reliability of measurements. This will involve reorientation of the axial, sagittal, and coronal planes using the Transforms module, followed by resampling and realignment of the region of interest using the Resample Scalar Volume and Crop modules within the 3D Slicer platform, respectively. Measurements will be standardized and oriented using the Transforms Reformat Widget Module. Spatial reference planes will be positioned in the mandibular buccal segment (MBS) and the interradicular zone (IZC) to ensure repeatability and reliability. Linear measurements of bone thickness will be conducted using the Markups module. For MBS, measurements will be taken on four coronal slices passing through the mesial and distal roots of the second mandibular molar and tangential to the proximal surfaces. Similarly, in the IZC region, measurements will be taken on five coronal slices passing through the mesiobuccal and distobuccal roots of the first and second maxillary molars and tangential to the proximal surfaces. Bone thickness and density will be assessed according to established classification systems. The cancellous bone density will be classified based on grayscale values obtained from the Segment Statistics module within the 3D Slicer platform.
Intervention type
Procedure/Surgery
Primary outcome measure
Cortical bone thickness in the infrazygomatic crest (IZC) and mandibular buccal shelf (MBS) regions measured using cone beam computed tomography (CBCT) scanning at a single timepoint post-scan acquisition
Secondary outcome measures
1. Cancellous bone density in the infrazygomatic crest (IZC) and mandibular buccal shelf (MBS) regions measured using cone beam computed tomography (CBCT) scanning at a single timepoint post-scan acquisition
2. Overall bone widths (cortical and cancellous) in the IZC and MBS regions measured using CBCT scanning at a single timepoint post-scan acquisition
Overall study start date
01/12/2022
Overall study end date
01/12/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Radiographic examinations (CBCT) performed for orthodontic purposes
2. Patients between 18 and 50 years of age
3. Patients in good health
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
50 Years
Sex
Both
Target number of participants
54
Total final enrolment
54
Participant exclusion criteria
1. Radiographic examinations (CBCT) performed for prosthetic planning or orthognathic surgery
2. CBCT images with motion artefacts due to patient movement during the scanning process
3. CBCT images with metal artefacts due to the presence of dental implants, amalgam filling, etc
4. Patients aged under 18 or over 50
5. Patients previously undergoing oral rehabilitation with zygomatic implants
6. Patients with a history of fractures in the region of interest
7. Patients with congenital craniofacial abnormalities (e.g. micrognathia, cleft lip or palate, etc)
8. Patients with systemic or local pathologies that affect bone metabolism
9. Patients under bisphosphonate therapy
Recruitment start date
01/04/2024
Recruitment end date
30/09/2024
Locations
Countries of recruitment
Italy
Study participating centre
Dental Clinic - University of L'Aquila
Via G. Petrini, Building “Rita Levi Montalcini”
L'Aquila
67100
Italy
Sponsor information
Organisation
University of L'Aquila
Sponsor details
Piazzale Salvatore Tommasi 1
Coppito
L’Aquila
67100
Italy
+39 0862433652
mesva.dir@univaq.it
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
Università degli Studi dell'Aquila
Alternative name(s)
University of L'Aquila
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
Intention to publish date
01/01/2025
Individual participant data (IPD) sharing plan
The datasets generated during and/or analyzed during the current study will be stored in a publicly available repository. The repository can be accessed via the following link: https://docs.google.com/spreadsheets/d/1DlTQWyGkKMkS6kyR1YVb0Lu4QLAe44F9/edit?usp=sharing&ouid=107268639835396758852&rtpof=true&sd=true
Type of Data Shared:
Raw data obtained from measurements.
Availability of Data:
The data will be available immediately. As measurements are conducted, they will be added to the case report form. At the conclusion of the study, the data will remain available indefinitely.
Access Criteria:
The data will be accessible for evaluation, analysis, or comparison purposes. There are no specific access criteria; the data will be openly accessible to anyone interested.
Purpose of Data Sharing:
The data will be shared for the purpose of evaluation, analysis, or comparison.
Consent from Participants:
Participants have consented to the sharing of their anonymized data for research purposes.
Data Anonymization:
All data shared will be anonymized to protect the privacy and confidentiality of participants.
Ethical or Legal Restrictions:
There are no ethical or legal restrictions on the sharing of this data.
Other Comments:
The repository will facilitate transparency and reproducibility in research by providing access to the raw data obtained from measurements conducted during the study.
IPD sharing plan summary
Stored in publicly available repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 23/02/2024 | No | Yes | ||
| Protocol file | 13/02/2024 | 23/02/2024 | No | No |