The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal
1 other identifier
interventional
477
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 11, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 4, 2015
March 1, 2015
1 year
February 11, 2014
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with inferior alveolar nerve (IAN) injury
1 week after surgery
Secondary Outcomes (1)
Change in Oral Health related quality of life score
1 week after surgery
Other Outcomes (1)
Costs of imaging, treatment and day's of work.
2 weeks after surgery
Study Arms (2)
CBCT
OTHERCone Beam CT
Panoramic radiograph
OTHERInterventions
Surgically removing the third molar in the lower jaw
Eligibility Criteria
You may qualify if:
- Adults \>18 year
- mandibular canal is superimposed more than one half by the roots of the third molar as assessed on panoramic radiograph.
You may not qualify if:
- pregnancy
- radiological evidence of cyst an tumors
- indication for removal under general anesthesia
- preoperative neurosensory alterations
- existence of an external CBCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery
Nijmegen, 6500HB, Netherlands
Related Publications (1)
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.
PMID: 26596360DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2014
First Posted
February 25, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 4, 2015
Record last verified: 2015-03