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

NCT ID: NCT02071030

Last Updated: 2015-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Inferior Alveolar Nerve Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBCT

Cone Beam CT

Group Type OTHER

Third molar removal

Intervention Type PROCEDURE

Surgically removing the third molar in the lower jaw

Panoramic radiograph

Group Type OTHER

Third molar removal

Intervention Type PROCEDURE

Surgically removing the third molar in the lower jaw

Interventions

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Third molar removal

Surgically removing the third molar in the lower jaw

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 26596360 (View on PubMed)

Other Identifiers

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NL nr.: 40492.091.12

Identifier Type: -

Identifier Source: org_study_id

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