Inferior Alveolar Nerve InjuryNCT02071030
The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal
A study testing Third molar removal in people with Inferior Alveolar Nerve Injury, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Injury
- What is being tested?
- Third molar removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >18 year
- mandibular canal is superimposed more than one half by the roots of the third molar as assessed on panoramic radiograph.
Who cannot join
- pregnancy
- radiological evidence of cyst an tumors
- indication for removal under general anesthesia
- preoperative neurosensory alterations
- existence of an external CBCT
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Centre. Department of Oral & Maxillofacial Surgery
Nijmegen, 6500HB
About this study
Official title: The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal; a Multicentre Randomised Controlled Trial
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.
- Conditions
- Inferior Alveolar Nerve Injury
- Being tested
- Third molar removal
- Keywords
- CBCT, Third molar removal, Inferior alveolar nerve injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar removalProcedure or surgery
Surgically removing the third molar in the lower jaw
| Study group | Role | What they receive |
|---|---|---|
| CBCT | Other | Cone Beam CT Receives: Procedure: Third molar removal |
| Panoramic radiograph | Other | Not described Receives: Procedure: Third molar removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with inferior alveolar nerve (IAN) injury
Measured: 1 week after surgery
Secondary outcomes (1)
Change in Oral Health related quality of life score
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071030
- Sponsor's protocol ID
- NL nr.: 40492.091.12
- Status last verified
- Mar 2015
- First submitted
- 11 Feb 2014
- Last updated
- 4 Mar 2015
- Results posted
- No
Publications
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.
PubMed 26596360
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cone Beam Computed Tomography (CBCT) Compared to Panoramic Radiography Prior to Third Molar Removal; a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02071030
- Acronym / sponsor ID
- NL nr.: 40492.091.12
- Conditions
- Inferior Alveolar Nerve Injury
- Keywords
- CBCT, Third molar removal, Inferior alveolar nerve injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBCT | Other | Procedure: Third molar removalCone Beam CT |
| Panoramic radiograph | Other | Procedure: Third molar removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults >18 year
- mandibular canal is superimposed more than one half by the roots of the third molar as assessed on panoramic radiograph.
Key exclusion criteria (5 listed)
- pregnancy
- radiological evidence of cyst an tumors
- indication for removal under general anesthesia
- preoperative neurosensory alterations
- existence of an external CBCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third molar removalSurgically removing the third molar in the lower jaw | Procedure or surgery | CBCT, Panoramic radiograph |
Primary outcome
Number of participants with inferior alveolar nerve (IAN) injury
Time frame: 1 week after surgery
1 secondary outcome
Change in Oral Health related quality of life score
Time frame: 1 week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Derived from this study: PubMed 26596360Ghaeminia 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.
Related trials for Inferior Alveolar Nerve Injury
Not yet recruiting
Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery
Infraorbital Nerve Injury, Inferior Alveolar Nerve Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third molar removal in people with Inferior Alveolar Nerve Injury, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with inferior alveolar nerve (IAN) injury (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02071030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.