NCT05946317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 18, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

June 12, 2023

Last Update Submit

July 14, 2023

Conditions

Keywords

Impacted third molarlingual nervelingual flap retractor

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 hours after the surgical procedure of removal of impacted mandibular third molar.

  • Nerve discrepancy

    0 : No sensational impairment 1. : Mild loss of sensation 2. : Moderate loss of sensation 3. : Severe loss of sensation

    6 hours after the surgical procedure of removal of impacted mandibular third molar.

  • Taste function

    Taste function is assessed by Taste sensation tests of sweetness, saltiness, acidity and bitterness.

    6 hours after the surgical procedure of removal of impacted mandibular third molar.

Secondary Outcomes (6)

  • Healing time

    Two weeks after the surgical procedure.

  • Healing time

    Four weeks after the surgical procedure.

  • Healing time

    Six weeks after the surgical procedure.

  • Healing time

    Two months after the surgical procedure.

  • Healing time

    Four months after the surgical procedure.

  • +1 more secondary outcomes

Study Arms (1)

Lingual nerve function assessed after removal of Impacted mandibular third molar

EXPERIMENTAL

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.

Procedure: Lingual nerve function assessed after removal of mandibular third molar with lingual split technique

Interventions

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.

Lingual nerve function assessed after removal of Impacted mandibular third molar

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaa Alaji

Latakia, Syria

Location

Related Publications (6)

  • 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.

    PMID: 6582236BACKGROUND
  • 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.

    PMID: 18088862BACKGROUND
  • 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.

    PMID: 28142010BACKGROUND
  • 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.

    PMID: 15346365BACKGROUND
  • 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.

    PMID: 22883979BACKGROUND
  • 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.

    PMID: 16884649BACKGROUND

MeSH Terms

Conditions

Lingual Nerve Injuries

Condition Hierarchy (Ancestors)

Trigeminal Nerve InjuriesTrigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Abdul Karim Khalil, PHD

    Tishreen University

    STUDY CHAIR
  • Alaa Alaji, Master

    Tishreen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 14, 2023

Study Start

December 1, 2021

Primary Completion

November 28, 2022

Study Completion

December 5, 2022

Last Updated

July 18, 2023

Record last verified: 2023-06

Locations