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CompletedNCT02071030Updated Mar 4, 2015

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

An interventional study of Third molar removal in Inferior Alveolar Nerve Injury, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-04.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
477
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Inferior Alveolar Nerve Injury

Keywords

  • CBCT
  • Third molar removal
  • Inferior alveolar nerve injury
03

In context

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
477 participants (actual)

Study arms

  • Other
    CBCT

    Cone Beam CT

    Procedure: Third molar removal

  • Other
    Panoramic radiograph

    Procedure: Third molar removal

Interventions

  • ProcedureThird molar removal

    Surgically removing the third molar in the lower jaw

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What researchers measure

Primary outcomes

  1. Number of participants with inferior alveolar nerve (IAN) injury

    Time frame: 1 week after surgery

Secondary outcomes

  1. Change in Oral Health related quality of life score

    Time frame: 1 week after surgery

Other outcomes

  1. Costs of imaging, treatment and day's of work.

    Time frame: 2 weeks after surgery

07

Study locations

1 site
  • Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery
    Nijmegen, 6500HB, Netherlands
08

References and documents

Publications

  • Ghaeminia H, Gerlach NL, Hoppenreijs TJ, Kicken M, Dings JP, Borstlap WA, de Haan T, Berge SJ, Meijer GJ, Maal TJ. Clinical relevance of cone beam computed tomography in mandibular third molar removal: A multicentre, randomised, controlled trial. J Craniomaxillofac Surg. 2015 Dec;43(10):2158-67. doi: 10.1016/j.jcms.2015.10.009. Epub 2015 Oct 23. PubMed 26596360 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02071030
Lead sponsor
Radboud University Medical Center
Responsible party
Sponsor
First posted
Feb 25, 2014
Start date
Jun 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Mar 4, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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