Impacted TeethNCT01002131
Exact Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography
An observational study of Impacted Teeth, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this investigation is an exact preoperative 3D-localisation of impacted and supernumerary teeth in the maxilla using Cone Beam Computer Tomography Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impacted Teeth
- What is being tested?
- CBCT
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- May 2007to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients at the St.Olavs University Hospital with impacted and supernummerary teeth in the maxilla who are scheduled to have surgery
Who may be able to join
- supernumerary and impacted teeth in the maxilla (wisdom teeth excluded)
- need for surgical removement
- uncertain clinical and conventional radiological finding
Who cannot join
- refused approval
- CBCT not practicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exact Three-dimensional Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography
The purpose of this investigation is an exact preoperative 3D-localisation of impacted and supernumerary teeth in the maxilla using Cone Beam Computer Tomography
Read the detailed description
An exact localisation of impacted teeth is often difficult to assume by using conventional radiological techniques like OPT or dental films. In contrast to these two-dimensional imaging methods the Cone Beam Computer Tomography (CBCT) respectively the Digital Volume Tomography (DVT) offers a three-dimensional imaging of the maxillofacial region, providing the opportunity to study objectives in all standard plans with 3D-reconstruction in multisection views.
A preoperative radiological investigation using CBCT on patients who are supposed to undergo surgery for impacted and supernumerary teeth in the frontal maxilla shall clarify the certainty and safeness of this 3D-imaging method. Therefore a comparison between the findings on the CBCT, on eventually former conventional x-rays and the intraoperative finding as gold standard is done.
- Conditions
- Impacted Teeth
- Being tested
- CBCT
- Keywords
- Digital Volume Tomography, Cone Beam CT, impacted and supernumerary teeth, dental and maxillofacial radiology
- Medical subject headings
- Tooth, Impacted, Tooth, Supernumerary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTDevice
Also called Cone Beam Tomography, i-Cat device, digital volume tomography (DVT)
Cone Beam Computer Tomography. 3D-imaging Digital Volume Tomography, compared with gold standard intraoperative findings.
| Study group | Role | What they receive |
|---|---|---|
| Digital Volume tomography | three-dimensional digital imaging using cone beam tomography (CBCT) Receives: Device: CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
exact localisation of impacted teeth
Cone Beam Computer Tomography, vs gold standard intraoperative finding
Measured: preoperative and under surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startMay 2007
- Primary completionApr 2009
- Study completionSep 2009
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 Impacted TeethStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Christoph M Ziegler, Professor, Study director, NTNU / St.Olavs HospitalThomas R Klimowicz, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002131
- Sponsor's protocol ID
- 19236
- Status last verified
- Feb 2017
- First submitted
- 26 Oct 2009
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ziegler CM, Klimowicz TR. A comparison between various radiological techniques in the localization and analysis of impacted and supernumerary teeth. Indian J Dent Res. 2013 May-Jun;24(3):336-41. doi: 10.4103/0970-9290.117998.
PubMed 24025881
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exact Three-dimensional Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography
- ClinicalTrials.gov ID
- NCT01002131
- Acronym / sponsor ID
- 19236
- Conditions
- Impacted Teeth
- Keywords
- Digital Volume Tomography, Cone Beam CT, impacted and supernumerary teeth, dental and maxillofacial radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2007 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Oct 2009 (estimated)
- 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.
The purpose of this investigation is an exact preoperative 3D-localisation of impacted and supernumerary teeth in the maxilla using Cone Beam Computer Tomography
Detailed description
An exact localisation of impacted teeth is often difficult to assume by using conventional radiological techniques like OPT or dental films. In contrast to these two-dimensional imaging methods the Cone Beam Computer Tomography (CBCT) respectively the Digital Volume Tomography (DVT) offers a three-dimensional imaging of the maxillofacial region, providing the opportunity to study objectives in all standard plans with 3D-reconstruction in multisection views.
A preoperative radiological investigation using CBCT on patients who are supposed to undergo surgery for impacted and supernumerary teeth in the frontal maxilla shall clarify the certainty and safeness of this 3D-imaging method. Therefore a comparison between the findings on the CBCT, on eventually former conventional x-rays and the intraoperative finding as gold standard is done.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Volume tomography | – | Device: CBCTthree-dimensional digital imaging using cone beam tomography (CBCT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients at the St.Olavs University Hospital with impacted and supernummerary teeth in the maxilla who are scheduled to have surgery
Key inclusion criteria (3 listed)
- supernumerary and impacted teeth in the maxilla (wisdom teeth excluded)
- need for surgical removement
- uncertain clinical and conventional radiological finding
Key exclusion criteria (2 listed)
- refused approval
- CBCT not practicable
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 |
|---|---|---|
| CBCTAlso: Cone Beam Tomography, i-Cat device, digital volume tomography (DVT)Cone Beam Computer Tomography. 3D-imaging Digital Volume Tomography, compared with gold standard intraoperative findings. | Device | Digital Volume tomography |
Primary outcome
exact localisation of impacted teeth
Time frame: preoperative and under surgery
Cone Beam Computer Tomography, vs gold standard intraoperative finding
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 28 Feb 2017.
- Results publication: PubMed 24025881Ziegler CM, Klimowicz TR. A comparison between various radiological techniques in the localization and analysis of impacted and supernumerary teeth. Indian J Dent Res. 2013 May-Jun;24(3):336-41. doi: 10.4103/0970-9290.117998.
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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.
Christoph M Ziegler, Professor study director
NTNU / St.Olavs Hospital
Thomas R Klimowicz, PhD principal investigator
St. Olavs Hospital
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 Impacted Teeth, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 2 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 28 Feb 2017. 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 Norway. 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?
exact localisation of impacted teeth (time frame: preoperative and under surgery). 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 NCT01002131, 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 28 Feb 2017.