Alveolar CleftNCT06395077
Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation.
An observational study of Alveolar Cleft, run by Malmö University at 1 site in Sweden.
Trial summary
Evaluation of a Low-dose exposure CBCT protocol for post-graft evaluation of treatment of cleft patients Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- CBCT low-dose protocol
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- 26 May 2021to 25 Feb 2024
- 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 7 to 14 years
- All sexes
- Child
Study population: patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.
Who may be able to join
- patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation of Swedish Paediatric Patients With Alveolar Clefts
Evaluation of a Low-dose exposure CBCT protocol for post-graft evaluation of treatment of cleft patients
Read the detailed description
The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s). The field of view (FOV) was 6.0 cm x 6.0 cm, the rotation mode was 180 degrees, and voxel size was 0.125 mm. Volume was reconstructed in slices of 1-mm thickness and interval. The dose area products (DAP) were 423 mGy cm2 for the clinical, standard-dose protocol and 172 mGy cm2 for the low-dose protocol.
The aim was to establish if a low-dose protocol could provide diagnostically acceptable image quality for assessing bone healing after alveolar bone grafting.
- Conditions
- Alveolar Cleft
- Being tested
- CBCT low-dose protocol
- Keywords
- CBCT, Low-dose, Alveolar cleft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT low-dose protocolDiagnostic test
The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s).
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of post grafting in patients with clefts.
CBCT investigation after surgery of patients with alveolar clefts.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start26 May 2021
- Primary completion17 Jun 2022
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar CleftStudies 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
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, Kristina Hellén-Halme, Malmö University
- Investigators
- Kristina Hellén-Halme, Principal investigator, Malmo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395077
- Sponsor's protocol ID
- FO 2020/401
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vicente A, Cederhag J, Rashidi N, Wiedel AP, Becker M, Brogardh-Roth S, Shi XQ, Hellen-Halme K. Low-Dose Cone-Beam Computed Tomography in Swedish Pediatric Patients With Alveolar Clefts Following Alveolar Bone Grafting-A Clinical Study. Clin Exp Dent Res. 2024 Dec;10(6):e70021. doi: 10.1002/cre2.70021.
PubMed 39497332
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation of Swedish Paediatric Patients With Alveolar Clefts
- ClinicalTrials.gov ID
- NCT06395077
- Acronym / sponsor ID
- FO 2020/401
- Conditions
- Alveolar Cleft
- Keywords
- CBCT, Low-dose, Alveolar cleft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- 26 May 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 1 May 2024 (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.
Evaluation of a Low-dose exposure CBCT protocol for post-graft evaluation of treatment of cleft patients
Detailed description
The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s). The field of view (FOV) was 6.0 cm x 6.0 cm, the rotation mode was 180 degrees, and voxel size was 0.125 mm. Volume was reconstructed in slices of 1-mm thickness and interval. The dose area products (DAP) were 423 mGy cm2 for the clinical, standard-dose protocol and 172 mGy cm2 for the low-dose protocol.
The aim was to establish if a low-dose protocol could provide diagnostically acceptable image quality for assessing bone healing after alveolar bone grafting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.
Key inclusion criteria (1 listed)
- patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCT low-dose protocolThe patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s). | Diagnostic test | – |
Primary outcome
Evaluation of post grafting in patients with clefts.
Time frame: 2 years
CBCT investigation after surgery of patients with alveolar clefts.
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 1 May 2024.
- Derived from this study: PubMed 39497332Vicente A, Cederhag J, Rashidi N, Wiedel AP, Becker M, Brogardh-Roth S, Shi XQ, Hellen-Halme K. Low-Dose Cone-Beam Computed Tomography in Swedish Pediatric Patients With Alveolar Clefts Following Alveolar Bone Grafting-A Clinical Study. Clin Exp Dent Res. 2024 Dec;10(6):e70021. doi: 10.1002/cre2.70021.
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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 Hellén-Halme principal investigator
Malmo 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 Alveolar Cleft, 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 1 May 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 post grafting in patients with clefts. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395077, which also lists 1 linked publication.
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 1 May 2024.