Teeth; LesionNCT05519462
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?
An observational study of Teeth; Lesion and Tooth Diseases, run by Malmö University at 1 site in Sweden.
Trial summary
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar. CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Teeth; Lesion, Tooth Diseases
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2020to 15 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: adults
Who may be able to join
- a need for a CBCT investigation of the mandibula third molar
Who cannot join
- been involved in radiographic examinations for science beforer.
Trial locations and contacts
1 site in 1 country.
About this study
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar.
CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar.
Read the detailed description
Two CBCT scans were acquired of each examination site: one scan using the standard clinical protocol (90kV, 5mA, 9.4s) and one, the low-dose protocol (90kV, 2mA, 9.4s). All exposures were made with a Veraviewepocs 3D F40 (J Morita Corp.; Kyoto, Japan) using a field of view (FOV) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.
- Conditions
- Teeth; Lesion, Tooth Diseases
- Keywords
- CBCT
- Medical subject headings
- Tooth Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of radiographic images
landmarks
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Aug 2020
- Primary completion15 Nov 2020
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth; LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Hellén-Halme, Malmö University
- Investigators
- Kristina Hellen-Halme, professor, Study chair, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519462
- Sponsor's protocol ID
- FO2020-242
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?
- ClinicalTrials.gov ID
- NCT05519462
- Acronym / sponsor ID
- FO2020-242
- Conditions
- Teeth; Lesion, Tooth Diseases
- Keywords
- CBCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar.
CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar.
Detailed description
Two CBCT scans were acquired of each examination site: one scan using the standard clinical protocol (90kV, 5mA, 9.4s) and one, the low-dose protocol (90kV, 2mA, 9.4s). All exposures were made with a Veraviewepocs 3D F40 (J Morita Corp.; Kyoto, Japan) using a field of view (FOV) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults
Key inclusion criteria (1 listed)
- a need for a CBCT investigation of the mandibula third molar
Key exclusion criteria (1 listed)
- been involved in radiographic examinations for science beforer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of radiographic images
Time frame: 1 day
landmarks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Hellen-Halme, professor study chair
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Teeth; Lesion and Tooth Diseases, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of radiographic images (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.