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

Inferior Alveolar Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071030
• Other study ID #: NL nr.: 40492.091.12
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: March 3, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Inferior Alveolar Nerve Injury

Intervention

Procedure:
• Third molar removal
Surgically removing the third molar in the lower jaw

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Costs of imaging, treatment and day's of work.		2 weeks after surgery	No
Primary	Number of participants with inferior alveolar nerve (IAN) injury		1 week after surgery	No
Secondary	Change in Oral Health related quality of life score		1 week after surgery	No