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

Primary Purpose

Inferior Alveolar Nerve Injury

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Third molar removal
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inferior Alveolar Nerve Injury focused on measuring CBCT, Third molar removal, Inferior alveolar nerve injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CBCT

Panoramic radiograph

Arm Description

Cone Beam CT

Outcomes

Primary Outcome Measures

Number of participants with inferior alveolar nerve (IAN) injury

Secondary Outcome Measures

Change in Oral Health related quality of life score

Full Information

First Posted
February 11, 2014
Last Updated
March 3, 2015
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02071030
Brief Title
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal
Official Title
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal; a Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inferior Alveolar Nerve Injury
Keywords
CBCT, Third molar removal, Inferior alveolar nerve injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBCT
Arm Type
Other
Arm Description
Cone Beam CT
Arm Title
Panoramic radiograph
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Third molar removal
Intervention Description
Surgically removing the third molar in the lower jaw
Primary Outcome Measure Information:
Title
Number of participants with inferior alveolar nerve (IAN) injury
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Change in Oral Health related quality of life score
Time Frame
1 week after surgery
Other Pre-specified Outcome Measures:
Title
Costs of imaging, treatment and day's of work.
Time Frame
2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26596360
Citation
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.
Results Reference
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The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal

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