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Removal of Impacted Molars With Lingual Split Technique

Primary Purpose

Lingual Nerve Injuries

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Lingual nerve function assessed after removal of mandibular third molar with lingual split technique
Sponsored by
Tishreen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lingual Nerve Injuries focused on measuring Impacted third molar, lingual nerve, lingual flap retractor

Eligibility Criteria

19 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who have impacted mandibular third molar indicated for removal. Patients are healthy and have no systemic diseases (ASA1 ASA2). Patient's age is less than 25 years where the bone grain is still present and the use of the chisel and hammer is permitted. Patient's consent to surgical work and inclusion in the research. Exclusion Criteria: A deep impacted mandibular third molar which is close proximately to the neuro-vascular package, deep horizontal impaction, extreme disto-angular impaction. Patient's age is over 25 years. The lingual plate is thick.

Sites / Locations

  • Alaa Alaji

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lingual nerve function assessed after removal of Impacted mandibular third molar

Arm Description

20 patients who had have an impacted mandibular third molar indicated for extraction by lingual split technique with using Walter's lingual retractor for retracting lingual flap. The neurological function of the lingual nerve was assessed after the demise of local anesthesia, then the location of the disorder and taste function and healing time are determined by sensory neurological tests on a graphic map that divides the tongue into sextants.

Outcomes

Primary Outcome Measures

Lingual nerve injury location
The location of the disorder on the tongue is determined on a graphic map that divides the tongue into six sextants in each side: middle apical, lateral apical, middle, lateral, middle posterior and lateral posterior.
Nerve discrepancy
0 : No sensational impairment : Mild loss of sensation : Moderate loss of sensation : Severe loss of sensation
Taste function
Taste function is assessed by Taste sensation tests of sweetness, saltiness, acidity and bitterness.

Secondary Outcome Measures

Healing time
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Healing time
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Healing time
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Healing time
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Healing time
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Healing time
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.

Full Information

First Posted
June 12, 2023
Last Updated
July 14, 2023
Sponsor
Tishreen University
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1. Study Identification

Unique Protocol Identification Number
NCT05946317
Brief Title
Removal of Impacted Molars With Lingual Split Technique
Official Title
Evaluation of Sir William Kelsey Fry Technique in Lingual Surgical Removal of Impacted Lower Third Molar With Retraction Lingual Nerve
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tishreen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research assesses removal of mandibular third molars by the lingual split technique with using Walter's lingual retractor for retracting lingual flap, and evaluates the lingual nerve injury that may result after applying this technique. The research sample included 20 patients and their age under 25 years where the grain is clear. The lingual nerve is assessed by sensory neurological tests on a graphic map that divides the tongue into sextants.
Detailed Description
Although the scope of oral and maxillofacial surgery has expanded in many directions recently, the common or recurrent practice remains dentoalveolar surgery including impaction surgery. The main indication to extract is whether the third molar has involved in a disease process. Permanent injury of lingual and chorda tympani nerve (influenced by taste sensations) following removal mandibular third molar remains a clinical problem in oral and maxillofacial surgery. To reduce the risk of lingual nerve injury, the current protocols in North America accentuate raising a buccal flap and following a buccal approach during removal impacted mandibular third molar. However, there was no uniform success as a clinical reality showed. Many patients are still being referred to specialist centers for the management of lingual nerve injury. In most cases, the surgeon was not discerned of any incident that could cause the neurological injury. The alternative technique is Lingual split technique. Lingual split technique for removal impacted mandibular third molars introduced by Kelsey Fry and described by Ward in 1956 by removing a thin piece of disto-lingual bone and removing the tooth lingually. This technique is initially designed to remove distal and lingually inclined impacted mandibular third molar. This technique has not received much appreciation because of potential associated morbidity. Complications with this technique are potential damage to the lingual nerve, increasing hemorrhage from the lingual cohesive soft tissue, infection expansion to the sublingual or sublingual spaces and edema close to the airway. Several modifications have been made on the lingual split technique which they have reduced trauma and prevent complications. The advantages of this technique are easy, safety, less time-consuming and minimal tissue trauma and complications with good outcomes. Also, it allows obtaining the impacted third molar in one piece, and may be used as a donor tooth for non-restorable molar replacement. It has the advantage of reducing the volume of residual thrombosis when using sauzerization means. Few studies look specifically at the lingual split technique, which has been criticized for causing a high rate of lingual nerve injury and excluded for centuries. The independent basis in lingual spilt technique is that the lingual plate is much thinner than the buccal, especially in cases where the tooth is fully bone impacting. It is suitable for use in young patients only with a flexible bone where the grain is clear.6 The direction of the grain and the presence of the lingual prominence of the alveolar process allow the desired part of the bone plate to easily detach by chiseling and this makes the technique more rapid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lingual Nerve Injuries
Keywords
Impacted third molar, lingual nerve, lingual flap retractor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The research sample included 20 patients from the Faculty of Dentistry in Tishreen University and maxillofacial surgery department in Tishreen Hospital who had have an impacted mandibular third molar indicated for extraction and their age under 25 years.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lingual nerve function assessed after removal of Impacted mandibular third molar
Arm Type
Experimental
Arm Description
20 patients who had have an impacted mandibular third molar indicated for extraction by lingual split technique with using Walter's lingual retractor for retracting lingual flap. The neurological function of the lingual nerve was assessed after the demise of local anesthesia, then the location of the disorder and taste function and healing time are determined by sensory neurological tests on a graphic map that divides the tongue into sextants.
Intervention Type
Procedure
Intervention Name(s)
Lingual nerve function assessed after removal of mandibular third molar with lingual split technique
Intervention Description
The lingual split technique is based on using chisel and hammer in bone removing. After the buccal and lingual flaps are raised and retracted. Two buccal bone cutting with horizontal cutting up between them are performed, The disto-lingual bone fragment is fractured inward by placing the cutting edge of the chisel at 45 degrees with the surface of the bone and directed towards the lower second premolar of the opposite side. By maintaining the cutting edge of the chisel parallel to the external oblique ridge, a few light taps with the mallet will separate the lingual plate from the rest of the alveolar bone. And it released from soft tissues, buccally force is applied to roll the whole tooth lingually. The neurological function of the lingual nerve was assessed after the demise of local anesthesia, then the location of the disorder and taste function and healing time are determined by sensory neurological tests on a graphic map that divides the tongue into sextants.
Primary Outcome Measure Information:
Title
Lingual nerve injury location
Description
The location of the disorder on the tongue is determined on a graphic map that divides the tongue into six sextants in each side: middle apical, lateral apical, middle, lateral, middle posterior and lateral posterior.
Time Frame
6 hours after the surgical procedure of removal of impacted mandibular third molar.
Title
Nerve discrepancy
Description
0 : No sensational impairment : Mild loss of sensation : Moderate loss of sensation : Severe loss of sensation
Time Frame
6 hours after the surgical procedure of removal of impacted mandibular third molar.
Title
Taste function
Description
Taste function is assessed by Taste sensation tests of sweetness, saltiness, acidity and bitterness.
Time Frame
6 hours after the surgical procedure of removal of impacted mandibular third molar.
Secondary Outcome Measure Information:
Title
Healing time
Description
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Time Frame
Two weeks after the surgical procedure.
Title
Healing time
Description
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Time Frame
Four weeks after the surgical procedure.
Title
Healing time
Description
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Time Frame
Six weeks after the surgical procedure.
Title
Healing time
Description
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Time Frame
Two months after the surgical procedure.
Title
Healing time
Description
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Time Frame
Four months after the surgical procedure.
Title
Healing time
Description
The McGill Pain Questionnaire (MPQ), it is a useful tool for monitoring progression of neurosensory recovery. This is a 10 cm five-degree scale, with a degree marked every 2.5 cm. : complete absence of sensation. : Almost no sensation. : Reduced sensation. : Almost normal sensation. : Fully normal sensation.
Time Frame
Six months after the surgical procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have impacted mandibular third molar indicated for removal. Patients are healthy and have no systemic diseases (ASA1 ASA2). Patient's age is less than 25 years where the bone grain is still present and the use of the chisel and hammer is permitted. Patient's consent to surgical work and inclusion in the research. Exclusion Criteria: A deep impacted mandibular third molar which is close proximately to the neuro-vascular package, deep horizontal impaction, extreme disto-angular impaction. Patient's age is over 25 years. The lingual plate is thick.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Karim Khalil, PHD
Organizational Affiliation
Tishreen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alaa Alaji, Master
Organizational Affiliation
Tishreen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaa Alaji
City
Latakia
Country
Syrian Arab Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
6582236
Citation
Rud J. Reevaluation of the lingual split-bone technique for removal of impacted mandibular third molars. J Oral Maxillofac Surg. 1984 Feb;42(2):114-7. doi: 10.1016/0278-2391(84)90323-9. No abstract available.
Results Reference
background
PubMed Identifier
18088862
Citation
Farish SE, Bouloux GF. General technique of third molar removal. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):23-43, v-vi. doi: 10.1016/j.coms.2006.11.012.
Results Reference
background
PubMed Identifier
28142010
Citation
Pippi R, Spota A, Santoro M. Prevention of Lingual Nerve Injury in Third Molar Surgery: Literature Review. J Oral Maxillofac Surg. 2017 May;75(5):890-900. doi: 10.1016/j.joms.2016.12.040. Epub 2017 Jan 4.
Results Reference
background
PubMed Identifier
15346365
Citation
Pogrel MA, Goldman KE. Lingual flap retraction for third molar removal. J Oral Maxillofac Surg. 2004 Sep;62(9):1125-30. doi: 10.1016/j.joms.2004.04.013.
Results Reference
background
PubMed Identifier
22883979
Citation
Steel B. Lingual split versus surgical bur technique in the extraction of impacted mandibular third molars: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Sep;114(3):294-302. doi: 10.1016/j.tripleo.2011.07.028. Epub 2012 Jan 27.
Results Reference
background
PubMed Identifier
16884649
Citation
Smith MH, Lung KE. Nerve injuries after dental injection: a review of the literature. J Can Dent Assoc. 2006 Jul-Aug;72(6):559-64.
Results Reference
background

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Removal of Impacted Molars With Lingual Split Technique

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