Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar

NCT06538688 | Completed DMC

• 1 other identifier: OEIMTM
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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

Conditions

Inferior Alveolar Nerve Injuries

Keywords

Orthodontic extraction; impacted third molar; TAD

Outcome Measures

Primary Outcomes (1)

• Radiographically

  By measuring the amount of extrusion of the impacted tooth gained in millimetres Using CBCT

  6months

Secondary Outcomes (3)

• Clinical neurosensory assessment

  6months

• clinical brush stroke directional test

  6months

• Clinical Two-point discrimination test

  6months

Study Arms (1)

Participants

EXPERIMENTAL

Patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve

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

Interventions

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 PROCEDURE

Orthodontic extrusion of the impacted mandibular third molar of high-risk for nerve injury using maxillary TAD.

Also known as: Using temporary anchorage device (TAD)in the maxillary bone for traction of the impacted tooth before extraction

Participants

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (3)

Alexandria university

Alexandria, Egypt

Location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (6)

• 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.

  PMID: 33667345 BACKGROUND

• 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.

  PMID: 22901857 BACKGROUND

• 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.

  PMID: 18486807 BACKGROUND

• 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.

  PMID: 25882437 BACKGROUND

• 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.

  PMID: 18022488 BACKGROUND

• 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.

  PMID: 37326659 RESULT

MeSH Terms

Conditions

Mandibular Nerve Injuries

Condition Hierarchy (Ancestors)

Trigeminal Nerve Injuries; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Saeeda Osman, Professor Dr

  Alexandria University

  STUDY CHAIR

• Tarek Nasreldin, Ass.prof.

  Alexandria University

  STUDY DIRECTOR

• Tasneem Amer, Lecturer

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: Patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve requiring orthodontic extrusion of the impacted teeth before extraction

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: December 17, 2023
• Primary Completion: May 15, 2024
• Study Completion: July 20, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)