The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal

March 3, 2015 updated by: Radboud University Medical Center

The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal; a Multicentre Randomised Controlled Trial

The purpose of this study is to evaluate the efficacy and cost-effectiveness of Cone Beam Computed Tomography (CBCT) compared to panoramic radiography prior to removal of third molars in reducing patient's morbidity. Adults having a close relationship between the mandibular canal and one or both lower third molars, as diagnosed from digital panoramic radiographs will be recruited for this randomised controlled trial. In one trial arm, patients will receive the standard digital panoramic radiograph prior to third molar surgery. In the second arm, subjects will undergo an additional Cone Beam Computed Tomography (CBCT) prior to third molar surgery.

All patients require a postoperative visit one week after surgery to assess the outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

477

Phase

  • Not Applicable

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

  • Netherlands
      • Nijmegen, Netherlands, 6500HB
        • Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults >18 year
  • mandibular canal is superimposed more than one half by the roots of the third molar as assessed on panoramic radiograph.

Exclusion Criteria:

  • pregnancy
  • radiological evidence of cyst an tumors
  • indication for removal under general anesthesia
  • preoperative neurosensory alterations
  • existence of an external CBCT

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CBCT
Cone Beam CT
Procedure: Third molar removal
Surgically removing the third molar in the lower jaw
OTHER: Panoramic radiograph
Procedure: Third molar removal
Surgically removing the third molar in the lower jaw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with inferior alveolar nerve (IAN) injury
Time Frame: 1 week after surgery
1 week after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Oral Health related quality of life score
Time Frame: 1 week after surgery
1 week after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Costs of imaging, treatment and day's of work.
Time Frame: 2 weeks after surgery
2 weeks after surgery

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

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

June 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 21, 2014

First Posted (ESTIMATE)

February 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL nr.: 40492.091.12

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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