Measurement of orthodontic tooth movement with dental magnetic resonance imaging
| ISRCTN | ISRCTN12689212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12689212 |
| Secondary identifying numbers | CPMS1090 |
- Submission date
- 11/04/2024
- Registration date
- 11/04/2024
- Last edited
- 16/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The objective of this clinical investigation is to examine different types of gums before starting orthodontic treatment and to analyze how the soft and hard tissues around the lower front teeth change during the process of moving them with braces. We will be using a new technique called dental MRI, which doesn't involve radiation like traditional CBCT imaging, to examine the dimensions of both soft and hard tissues around the lower front teeth..
Who can participate?
Adolescent (aged 12 - 18 years) patients with substantial treatment need and crowding in the mandible.
What does the study involve?
In this study, we will examine different types of gums using both clinical assessments and imaging techniques such as CBCT scans and intraoral scans. Additionally, we will use a new method called dental magnetic resonance imaging (MRI), which can show both soft and hard tissues. We will compare the measurements obtained from CBCT and intraoral scanning with those from dental MRI. We're particularly interested in the thickness of the free gingiva, the gingiva above and below the crest of the bone, and the size of the bone around the lower front teeth. Throughout the treatment process, we will monitor the lower front teeth of the patients for five months using dental MRI.
What are the possible benefits and risks of participating?
Benefits of participation are the combination of radiologically assessed soft tissue dimensions and their monitoring throughout the initial treatment phase, ensuring that patients do not undergo unnecessary surgical procedures such as soft tissue augmentation, while at the same time selecting those who do require such a procedure.
Risks associated with the study interventions include patients experiencing claustrophobia during the MRI scan.
Where is the study run from?
Medical University of Vienna (Austria)
When is the study starting and how long is it expected to run for?
May 2021 to May 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Linda Schwarz, linda.schwarz@meduniwien.ac.at
Contact information
Public, Scientific, Principal Investigator
Sensengasse 2a
Vienna
1090
Austria
 ORCID ID |
0000-0003-0565-1155 |
|---|---|
| Phone | +43 1400704301 |
| linda.schwarz@meduniwien.ac.at |
Study information
| Study design | Prospective pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Dental clinic, University/medical school/dental school |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A novel approach for measurement of orthodontic tooth movement with dental magnetic resonance imaging |
| Study objectives | There is no statistical significant difference in tissue dimensions in patients before, and after start of orthodontic treatment |
| Ethics approval(s) |
Approved 06/07/2021, Ethics Committee of the Medical University of Vienna (Borschkegasse 8b, Vienna, 1090, Austria; +43 1 40400 21470; ethik-kom@meduniwien.ac.at), ref: 1654/2021 |
| Health condition(s) or problem(s) studied | Moderate to severe crowding in the mandible |
| Intervention | 2 MRI examinations, one before (T0) and one five months after (T1) start of orthodontic treatment. |
| Intervention type | Other |
| Primary outcome measure | Gingiva and bone thickness around the lower anterior teeth measured using MRI before (T0) and one five months after (T1) start of orthodontic treatment |
| Secondary outcome measures | Tooth movement measured using MRI before (T0) and one five months after (T1) start of orthodontic treatment |
| Overall study start date | 01/05/2021 |
| Completion date | 01/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Crowding in the mandible of >3mm 2. All permanent teeth in the mandible, no missing teeth in the mandible 3. >12 years of age, orthodontic treatment need (IOTN 4 or 5) |
| Key exclusion criteria | 1. Claustrophobia 2. Systemic diseases 3. Cranio-facial anomalies 4. Smoking |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 15/01/2025 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1090
Austria
Sponsor information
University/education
Spitalgasse 23
1090
1090
Austria
| Phone | +43 1 40160-0 |
|---|---|
| contact@meduniwien.ac.at | |
| Website | https://www.meduniwien.ac.at/web/ |
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study are not expected to be made avaiable due to the highly sensitive nature of radiologic datasets. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/05/2025 | 16/05/2025 | Yes | No |
Editorial Notes
16/05/2025: The following changes were made to the trial record:
1. The overall end date was changed from 01/05/2025 to 01/05/2024.
2. Publication reference added.
31/01/2025: The recruitment end date was changed from 01/01/2025 to 15/01/2025.
11/04/2024: Trial's existence confirmed by Ethics Committee of the Medical University of Vienna.
