Clinical trial NCT06538688: Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar
Official title: Evaluation of Orthodontic Extrusion of Impacted Mandibular Third Molar in Close Proximity to Inferior Alveolar Nerve Prior to Extraction ( a Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inferior Alveolar Nerve Injuries
Keywords: Orthodontic extraction
impacted third molar
TAD
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* patients with limitation in mouth opening.
* patients with mental or physical disabilities.
* Allergy to anaesthetic components or antibiotics.

Primary outcomes:
measure: Radiographically
timeFrame: 6months
Secondary outcomes:
measure: Clinical neurosensory assessment
timeFrame: 6months
measure: clinical brush stroke directional test
timeFrame: 6months
measure: Clinical Two-point discrimination test
timeFrame: 6months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Alexandria University
name: Saeeda Osman, Professor Dr
role: STUDY_CHAIR
affiliation: Alexandria University
name: Tarek Nasreldin, Ass.prof.
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Tasneem Amer, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kim 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.
citation: Ramaraj 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.
citation: Kalantar 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.
citation: Alessandri 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.
citation: Zhao 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.