Inferior Alveolar Nerve InjuriesNCT06538688
Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar
A study testing Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction in people with Inferior Alveolar Nerve Injuries, run by Alexandria University at 3 sites in Egypt.
Trial summary
The goal of this clinical trial is to investigate the usage of maxillary miniscrew and cross-arch elastics for the orthodontic traction of the impacted mandibular third molar in close proximity to the inferior alveolar nerve to decrease the chance of nerve injury Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Inferior Alveolar Nerve Injuries
- What is being tested?
- Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesEgypt
- Study dates
- 17 Dec 2023to 20 Jul 2024
- 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 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve.
- Cooperative patients free of chronic diseases which interfere with needed results (e.g.diseases affect the bone regeneration ).
- Patients with good oral hygiene.
Who cannot join
- patients with limitation in mouth opening.
- patients with mental or physical disabilities.
- Allergy to anaesthetic components or antibiotics.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Alexandria university
Alexandria
Faculty of Dentistry, Alexandria University
Alexandria
Faculty of Dentistry
Alexandria
About this study
Official title: Evaluation of Orthodontic Extrusion of Impacted Mandibular Third Molar in Close Proximity to Inferior Alveolar Nerve Prior to Extraction ( a Clinical Trial)
The goal of this clinical trial is to investigate the usage of maxillary miniscrew and cross-arch elastics for the orthodontic traction of the impacted mandibular third molar in close proximity to the inferior alveolar nerve to decrease the chance of nerve injury
Read the detailed description
To investigate the traction of the impacted mandibular third molar away from the inferior alveolar nerve by using the orthodontic miniscrew in the maxillary bone and cross-arch elastic power chain as a temporary anchorage device before extraction to avoid injury of the nerve and neurosensory complications.
- Conditions
- Inferior Alveolar Nerve Injuries
- Being tested
- Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction
- Keywords
- Orthodontic extraction, impacted third molar, TAD
- Medical subject headings
- Mandibular Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extractionProcedure or surgery
Also called Using temporary anchorage device (TAD)in the maxillary bone for traction of the impacted tooth before extraction
Orthodontic extrusion of the impacted mandibular third molar of high-risk for nerve injury using maxillary TAD.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve Receives: Procedure: Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographically
By measuring the amount of extrusion of the impacted tooth gained in millimetres Using CBCT
Measured: 6months
Secondary outcomes (3)
Clinical neurosensory assessment
By using pinprick test in which ;A sharp dental probe was applied to the skin over chin region, lip and mucosa in a quick pricking movement and pain perception of the patient was assessed. Each area was tested three times bilaterally.the scale ranged from 0-2, where 0= no sensation, 1= decreased sensation and 2= normal sensation.
Measured: 6months
clinical brush stroke directional test
using a micro brush tip which was moved in horizontal and/or vertical directions on the chin area ten times and asked the patient to reproduce the movements the scale ranged from 0-2, where 0= no sensation, 1= decreased sensation and 2= normal sensation.
Measured: 6months
Clinical Two-point discrimination test
By using probes of caliper device which were drawn across the skin at constant pressure and patient was asked whether one or two points were felt, the minimum separation distance was felt by the patient was termed two point discrimination threshold.scoring from 0-2 in which; 0=>15mm, 1=8-15, 2= <8 .
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start17 Dec 2023
- Primary completion15 May 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve requiring orthodontic extrusion of the impacted teeth before extraction
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mohamed Elmetwally Elmetwally, Alexandria University
- Investigators
- Saeeda Osman, Professor Dr, Study chair, Alexandria UniversityTarek Nasreldin, Ass.prof., Study director, Alexandria UniversityTasneem Amer, Lecturer, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538688
- Sponsor's protocol ID
- OEIMTM
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung S, Lee JH, Huh J, Park W. Orthodontic Extrusion of Mandibular Third Molar With a Miniscrew and Cross-Arch Elastic. J Oral Maxillofac Surg. 2021 Jul;79(7):1422.e1-1422.e8. doi: 10.1016/j.joms.2021.01.036. Epub 2021 Feb 7.
PubMed 33667345Kim JW, Cha IH, Kim SJ, Kim MR. Which risk factors are associated with neurosensory deficits of inferior alveolar nerve after mandibular third molar extraction? J Oral Maxillofac Surg. 2012 Nov;70(11):2508-14. doi: 10.1016/j.joms.2012.06.004. Epub 2012 Aug 15.
PubMed 22901857Ramaraj PN. Orthodontic extraction: the riskless extraction of the impacted lower third molars close to the mandibular canal. J Oral Maxillofac Surg. 2008 Jun;66(6):1317; author reply 1317. doi: 10.1016/j.joms.2008.02.008. No abstract available.
PubMed 18486807Kalantar Motamedi MR, Heidarpour M, Siadat S, Kalantar Motamedi A, Bahreman AA. Orthodontic Extraction of High-Risk Impacted Mandibular Third Molars in Close Proximity to the Mandibular Canal: A Systematic Review. J Oral Maxillofac Surg. 2015 Sep;73(9):1672-85. doi: 10.1016/j.joms.2015.03.031. Epub 2015 Mar 24.
PubMed 25882437Alessandri Bonetti G, Bendandi M, Laino L, Checchi V, Checchi L. Orthodontic extraction: riskless extraction of impacted lower third molars close to the mandibular canal. J Oral Maxillofac Surg. 2007 Dec;65(12):2580-6. doi: 10.1016/j.joms.2007.06.686. No abstract available.
PubMed 18022488Zhao S, Wang Y, Yang X, Zhou X, Wang Z, Zhang K, Yang X. Extraction of impacted mandibular third molars in close proximity to the inferior alveolar canal with coronectomy-miniscrew traction to avoid nerve injury. Clin Oral Investig. 2023 Aug;27(8):4279-4288. doi: 10.1007/s00784-023-05044-9. Epub 2023 Jun 16.
PubMed 37326659
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Orthodontic Extrusion of Impacted Mandibular Third Molar in Close Proximity to Inferior Alveolar Nerve Prior to Extraction ( a Clinical Trial)
- ClinicalTrials.gov ID
- NCT06538688
- Acronym / sponsor ID
- OEIMTM
- Conditions
- Inferior Alveolar Nerve Injuries
- Keywords
- Orthodontic extraction, impacted third molar, TAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- 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 goal of this clinical trial is to investigate the usage of maxillary miniscrew and cross-arch elastics for the orthodontic traction of the impacted mandibular third molar in close proximity to the inferior alveolar nerve to decrease the chance of nerve injury
Detailed description
To investigate the traction of the impacted mandibular third molar away from the inferior alveolar nerve by using the orthodontic miniscrew in the maxillary bone and cross-arch elastic power chain as a temporary anchorage device before extraction to avoid injury of the nerve and neurosensory complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve requiring orthodontic extrusion of the impacted teeth before extraction
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Procedure: Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extractionPatients with impacted mandibular third molar in close proximity to the inferior alveolar nerve |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve.
- Cooperative patients free of chronic diseases which interfere with needed results (e.g.diseases affect the bone regeneration ).
- Patients with good oral hygiene.
Key exclusion criteria (3 listed)
- patients with limitation in mouth opening.
- patients with mental or physical disabilities.
- Allergy to anaesthetic components or antibiotics.
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 |
|---|---|---|
| Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extractionAlso: Using temporary anchorage device (TAD)in the maxillary bone for traction of the impacted tooth before extractionOrthodontic extrusion of the impacted mandibular third molar of high-risk for nerve injury using maxillary TAD. | Procedure or surgery | Participants |
Primary outcome
Radiographically
Time frame: 6months
By measuring the amount of extrusion of the impacted tooth gained in millimetres Using CBCT
3 secondary outcomes
Clinical neurosensory assessment
Time frame: 6months
clinical brush stroke directional test
Time frame: 6months
Clinical Two-point discrimination test
Time frame: 6months
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 27 Aug 2024.
- Background: PubMed 33667345Jung S, Lee JH, Huh J, Park W. Orthodontic Extrusion of Mandibular Third Molar With a Miniscrew and Cross-Arch Elastic. J Oral Maxillofac Surg. 2021 Jul;79(7):1422.e1-1422.e8. doi: 10.1016/j.joms.2021.01.036. Epub 2021 Feb 7.
- Background: PubMed 22901857Kim JW, Cha IH, Kim SJ, Kim MR. Which risk factors are associated with neurosensory deficits of inferior alveolar nerve after mandibular third molar extraction? J Oral Maxillofac Surg. 2012 Nov;70(11):2508-14. doi: 10.1016/j.joms.2012.06.004. Epub 2012 Aug 15.
- Background: PubMed 18486807Ramaraj PN. Orthodontic extraction: the riskless extraction of the impacted lower third molars close to the mandibular canal. J Oral Maxillofac Surg. 2008 Jun;66(6):1317; author reply 1317. doi: 10.1016/j.joms.2008.02.008. No abstract available.
- Background: PubMed 25882437Kalantar Motamedi MR, Heidarpour M, Siadat S, Kalantar Motamedi A, Bahreman AA. Orthodontic Extraction of High-Risk Impacted Mandibular Third Molars in Close Proximity to the Mandibular Canal: A Systematic Review. J Oral Maxillofac Surg. 2015 Sep;73(9):1672-85. doi: 10.1016/j.joms.2015.03.031. Epub 2015 Mar 24.
- Background: PubMed 18022488Alessandri Bonetti G, Bendandi M, Laino L, Checchi V, Checchi L. Orthodontic extraction: riskless extraction of impacted lower third molars close to the mandibular canal. J Oral Maxillofac Surg. 2007 Dec;65(12):2580-6. doi: 10.1016/j.joms.2007.06.686. No abstract available.
- Results publication: PubMed 37326659Zhao S, Wang Y, Yang X, Zhou X, Wang Z, Zhang K, Yang X. Extraction of impacted mandibular third molars in close proximity to the inferior alveolar canal with coronectomy-miniscrew traction to avoid nerve injury. Clin Oral Investig. 2023 Aug;27(8):4279-4288. doi: 10.1007/s00784-023-05044-9. Epub 2023 Jun 16.
- Individual participant dataSharing planned: No
Related trials for Inferior Alveolar Nerve Injuries
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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.
Saeeda Osman, Professor Dr study chair
Alexandria University
Tarek Nasreldin, Ass.prof. study director
Alexandria University
Tasneem Amer, Lecturer study director
Alexandria University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction in people with Inferior Alveolar Nerve Injuries, run by Alexandria University at 3 sites in Egypt.
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 3 inclusion and 3 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
Radiographically (time frame: 6months). 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 NCT06538688, which also lists 6 linked publications.
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 27 Aug 2024.