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
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
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
NCT ID
NCT02071030
First Posted
February 11, 2014
Last Updated
March 3, 2015
Sponsor
Radboud University Medical Center
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
derived
Learn more about this trial
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal
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