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

February 24, 2017 updated by: Norwegian University of Science and Technology

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exact localisation of impacted teeth
Time Frame: preoperative and under surgery
Cone Beam Computer Tomography, vs gold standard intraoperative finding
preoperative and under surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Christoph M Ziegler, Professor, NTNU / St.Olavs Hospital
  • Principal Investigator: Thomas R Klimowicz, PhD, St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19236

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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