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Exact Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography

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ClinicalTrials.gov Identifier: NCT01002131
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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

Condition or disease Intervention/treatment
Impacted Teeth Device: CBCT

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 Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Exact Three-dimensional Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography
Actual Study Start Date : May 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : September 2009

Group/Cohort Intervention/treatment
Digital Volume tomography
three-dimensional digital imaging using cone beam tomography (CBCT)
Device: CBCT
Cone Beam Computer Tomography. 3D-imaging Digital Volume Tomography, compared with gold standard intraoperative findings.
Other Names:
  • Cone Beam Tomography
  • i-Cat device
  • digital volume tomography (DVT)




Primary Outcome Measures :
  1. exact localisation of impacted teeth [ Time Frame: preoperative and under surgery ]
    Cone Beam Computer Tomography, vs gold standard intraoperative finding



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients at the St.Olavs University Hospital with impacted and supernummerary teeth in the maxilla who are scheduled to have surgery
Criteria

Inclusion Criteria:

  • supernumerary and impacted teeth in the maxilla (wisdom teeth excluded)
  • need for surgical removement
  • uncertain clinical and conventional radiological finding

Exclusion Criteria:

  • refused approval
  • CBCT not practicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002131


Locations
Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Christoph M Ziegler, Professor NTNU / St.Olavs Hospital
Principal Investigator: Thomas R Klimowicz, PhD St. Olavs Hospital

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01002131     History of Changes
Other Study ID Numbers: 19236
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Digital Volume Tomography
Cone Beam CT
impacted and supernumerary teeth
dental and maxillofacial radiology

Additional relevant MeSH terms:
Tooth, Impacted
Tooth, Supernumerary
Tooth Diseases
Stomatognathic Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities