The Efficacy of Cone Beam Computed Tomography (CBCT) Comp... | NCT02071030

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

NCT02071030

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Mar 4, 2015Estimated

Enrollment

477Actual

Phase

Not Applicable

Conditions

Inferior Alveolar Nerve Injury

Interventions

Third molar removal

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Feb 11, 2014

First Submission Date that Met QC Criteria

Feb 21, 2014

First Posted Date

Feb 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2015

Last Update Posted Date

Mar 4, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

477Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBCT	Other	Cone Beam CT	Procedure: Third molar removal
Panoramic radiograph	Other		Procedure: Third molar removal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Third molar removal	Procedure	Surgically removing the third molar in the lower jaw	CBCT Panoramic radiograph

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with inferior alveolar nerve (IAN) injury		1 week after surgery

Secondary Outcomes

Measure	Description	Time Frame
Change in Oral Health related quality of life score		1 week after surgery

Other Outcomes

Measure	Description	Time Frame
Costs of imaging, treatment and day's of work.		2 weeks after surgery

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery		Nijmegen		6500HB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26596360	Derived	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.