Lingual Nerve InjuriesNCT05946317
Removal of Impacted Molars With Lingual Split Technique
A study testing Lingual nerve function assessed after removal of mandibular third molar with lingual split technique in people with Lingual Nerve Injuries, run by Latakia University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Lingual Nerve Injuries
- What is being tested?
- Lingual nerve function assessed after removal of mandibular third molar with lingual split technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2021to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sir William Kelsey Fry Technique in Lingual Surgical Removal of Impacted Lower Third Molar With Retraction Lingual Nerve
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.
Read the 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.
- Conditions
- Lingual Nerve Injuries
- Being tested
- Lingual nerve function assessed after removal of mandibular third molar with lingual split technique
- Keywords
- Impacted third molar, lingual nerve, lingual flap retractor
- Medical subject headings
- Lingual Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual nerve function assessed after removal of mandibular third molar with lingual split techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lingual nerve function assessed after removal of mandibular third molar with lingual split technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after the surgical procedure of removal of impacted mandibular third molar.
Nerve discrepancy
0 : No sensational impairment
- : Mild loss of sensation
- : Moderate loss of sensation
- : Severe loss of sensation
Measured: 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.
Measured: 6 hours after the surgical procedure of removal of impacted mandibular third molar.
Secondary outcomes (6)
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.
Measured: Two weeks after the surgical procedure.
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.
Measured: Four weeks after the surgical procedure.
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.
Measured: Six weeks after the surgical procedure.
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.
Measured: Two months after the surgical procedure.
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.
Measured: Four months after the surgical procedure.
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.
Measured: Six months after the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Dec 2021
- Primary completion28 Nov 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lingual Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Karim Khalil, PHD, Study chair, Latakia UniversityAlaa Alaji, Master, Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946317
- Sponsor's protocol ID
- TishreenU - Maxillofacial surg
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 6582236Farish 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.
PubMed 18088862Pippi 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.
PubMed 28142010Pogrel 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.
PubMed 15346365Steel 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.
PubMed 22883979Smith MH, Lung KE. Nerve injuries after dental injection: a review of the literature. J Can Dent Assoc. 2006 Jul-Aug;72(6):559-64.
PubMed 16884649
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sir William Kelsey Fry Technique in Lingual Surgical Removal of Impacted Lower Third Molar With Retraction Lingual Nerve
- ClinicalTrials.gov ID
- NCT05946317
- Acronym / sponsor ID
- TishreenU - Maxillofacial surg
- Conditions
- Lingual Nerve Injuries
- Keywords
- Impacted third molar, lingual nerve, lingual flap retractor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lingual nerve function assessed after removal of Impacted mandibular third molar | Experimental | Procedure: Lingual nerve function assessed after removal of mandibular third molar with lingual split technique20 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. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lingual nerve function assessed after removal of mandibular third molar with lingual split techniqueThe 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. | Procedure or surgery | Lingual nerve function assessed after removal of Impacted mandibular third molar |
Primary outcome
Lingual nerve injury location
Time frame: 6 hours after the surgical procedure of removal of impacted mandibular third molar.
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
Time frame: 6 hours after the surgical procedure of removal of impacted mandibular third molar.
0 : No sensational impairment 1. : Mild loss of sensation 2. : Moderate loss of sensation 3. : Severe loss of sensation
Taste function
Time frame: 6 hours after the surgical procedure of removal of impacted mandibular third molar.
Taste function is assessed by Taste sensation tests of sweetness, saltiness, acidity and bitterness.
6 secondary outcomes
Healing time
Time frame: Two weeks after the surgical procedure.
Healing time
Time frame: Four weeks after the surgical procedure.
Healing time
Time frame: Six weeks after the surgical procedure.
Healing time
Time frame: Two months after the surgical procedure.
Healing time
Time frame: Four months after the surgical procedure.
Healing time
Time frame: Six months after the surgical procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 6582236Rud 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.
- Background: PubMed 18088862Farish 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.
- Background: PubMed 28142010Pippi 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.
- Background: PubMed 15346365Pogrel 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.
- Background: PubMed 22883979Steel 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.
- Background: PubMed 16884649Smith MH, Lung KE. Nerve injuries after dental injection: a review of the literature. J Can Dent Assoc. 2006 Jul-Aug;72(6):559-64.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Karim Khalil, PHD study chair
Latakia University
Alaa Alaji, Master principal investigator
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual nerve function assessed after removal of mandibular third molar with lingual split technique in people with Lingual Nerve Injuries, run by Latakia University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lingual nerve injury location (time frame: 6 hours after the surgical procedure of removal of impacted mandibular third molar.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05946317, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.