NCT01002131

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

October 26, 2009

Last Update Submit

February 24, 2017

Conditions

Impacted Teeth

Keywords

Digital Volume TomographyCone Beam CTimpacted and supernumerary teethdental and maxillofacial radiology

Outcome Measures

Primary Outcomes (1)

  • exact localisation of impacted teeth

    Cone Beam Computer Tomography, vs gold standard intraoperative finding

    preoperative and under surgery

Study Arms (1)

Digital Volume tomography

three-dimensional digital imaging using cone beam tomography (CBCT)

Device: CBCT

Interventions

CBCTDEVICE

Cone Beam Computer Tomography. 3D-imaging Digital Volume Tomography, compared with gold standard intraoperative findings.

Also known as: Cone Beam Tomography, i-Cat device, digital volume tomography (DVT)
Digital Volume tomography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • refused approval
  • CBCT not practicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 24025881RESULT

MeSH Terms

Conditions

Tooth, ImpactedTooth, Supernumerary

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christoph M Ziegler, Professor

    NTNU / St.Olavs Hospital

    STUDY DIRECTOR

  • Thomas R Klimowicz, PhD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

May 1, 2007

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

NO(1)