Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar

August 25, 2024 updated by: Azza Mohamed Elmetwally Elmetwally, Alexandria University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Dentistry, Alexandria University
      • Alexandria, Egypt
        • Alexandria University
      • Alexandria, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
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
Orthodontic extrusion of the impacted mandibular third molar of high-risk for nerve injury using maxillary TAD.
Other Names:
  • Using temporary anchorage device (TAD)in the maxillary bone for traction of the impacted tooth before extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographically
Time Frame: 6months
By measuring the amount of extrusion of the impacted tooth gained in millimetres Using CBCT
6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical neurosensory assessment
Time Frame: 6months
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.
6months
clinical brush stroke directional test
Time Frame: 6months
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.
6months
Clinical Two-point discrimination test
Time Frame: 6months
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 .
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Saeeda Osman, Professor Dr, Alexandria University
  • Study Director: Tarek Nasreldin, Ass.prof., Alexandria University
  • Study Director: Tasneem Amer, Lecturer, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

July 20, 2024

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OEIMTM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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