Inferior Alveolar Nerve InjuriesNCT06270784
Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve
A study testing Traditional Extraction and Orthodontic Extraction in people with Inferior Alveolar Nerve Injuries, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Injuries
- What is being tested?
- Traditional Extraction and Orthodontic Extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2024to 6 Nov 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of indication for wisdom tooth extraction for reasons such as pericoronitis, pathological formation, orthodontic reasons, caries, etc.
- Mandibular impacted wisdom teeth close to the inferior alveolar nerve
Who cannot join
- Mandibular impacted wisdom tooth not close to inferior alveolar nerve
- Wisdom tooth whose apexification has not yet been completed
- Suspicion of a malignant pathological lesion
- Pathological lesion associated with inferior alveolar nerve
- Presence of an acute infection
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:
-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?
Participants will:
- undergo either traditional or orthodontic extraction
- be monitored for postoperative paresthesia.
Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage.
Read the detailed description
The extraction of an impacted mandibular third molar is one of the most frequently performed procedures by oral and maxillofacial surgeons. The close anatomical relationship between the root of an impacted mandibular third molar and the inferior alveolar nerve may result in inferior alveolar nerve damage. The incidence of inferior alveolar nerve injury during the removal of an impacted mandibular third molar ranges from 0.35% to 8.4%. In addition to radiographic analysis, various surgical techniques, such as coronectomy, have been proposed to reduce the incidence of inferior alveolar nerve injury.
The orthodontic extraction technique is an orthodontically supported surgical approach that reduces the risk of neurological complications that may occur in inferior alveolar nerve and facilitates the surgical removal of impacted mandibular third molars close to the mandibular canal, even if they are associated with cystic lesions.
The purpose of this study is to examine the effect of orthodontic extraction applied to minimize inferior alveolar nerve damage during the extraction of deeply impacted mandibular third molar teeth on postoperative nerve injury. For this purpose, the postoperative paresthesia findings of patients who underwent orthodontic extraction will be compared with those of those who underwent traditional extraction.
- Conditions
- Inferior Alveolar Nerve Injuries
- Being tested
- Traditional Extraction, Orthodontic Extraction
- Keywords
- Mandibular nerve injuries, impacted teeth, tooth extraction
- Medical subject headings
- Mandibular Nerve Injuries, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ExtractionProcedure or surgery
Participants in this group will undergo traditional extraction method. This method involves uncovering the impacted tooth and extracting the tooth with or without dividing it.
Orthodontic ExtractionProcedure or surgery
Participants in this group will undergo orthodontic extraction method. In this method, a two-stage surgical procedure will be performed. In the first operation, the impacted tooth will be uncovered, and then a button will be placed on the tooth. For anchorage purposes, orthodontic mini screws will be placed in the mandibular ramus or zygomaticomaxillary buttress area. Elastics and/or ligature wires fixed to the button will be attached to the mini screw to provide force for the traction of the tooth.
Patients will be called for check-up appointments every two weeks, and the movement of the impacted tooth will be monitored with panoramic x-rays. The second operation will be planned when the tooth moves away from the inferior alveolar nerve. In the second operation, the tooth will be extracted in a similar way to the traditional extraction group.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Extraction Group | Active comparator | Not described Receives: Procedure: Traditional Extraction |
| Orthodontic Extraction Group | Experimental | Not described Receives: Procedure: Orthodontic Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-point discrimination test on the 7th day after surgery
The primary outcome measure of the study was the assessment of nerve injury. For this purpose, postoperative nerve injury will be recorded by a 2-point discrimination test with the help of a caliper with a 1mm gap.
Measured: A 2-point discrimination test will be performed before the extraction and 7 days after extraction in both groups.
Secondary outcomes (3)
Visual Analog Score(VAS)
To measure the degree of nerve injury, the patient will be asked to choose a score based on the degree of numbness, where 0 indicates complete numbness and 10 indicates complete normal sensation.
Measured: VAS will be evaluated on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.
2-point discrimination test on the 14th days and the 1st, 3rd, and 6th months after extraction.
Nerve injury will be recorded by a 2-point discrimination test with the help of a caliper with a 1mm gap.
Measured: A 2-point discrimation test will be performed on the 14th days and the 1st, 3rd, and 6th months after extraction.
Inferior alveolar nerve recovery
The effect of demographic data such as age, gender, and tooth position on IAN recovery will be evaluated. At postoperative time points, 2-point discrimation test values that are 2 mm more than the preoperative result will be considered to indicate nerve injury.
Measured: Inferior alveolar nerve recovery will be assessed on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start17 Jan 2024
- Primary completion6 May 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Askin Ekinci, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270784
- Sponsor's protocol ID
- 09.2024.122
- Status last verified
- Sep 2024
- First submitted
- 13 Feb 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Askin Ekinci S, Kiristioglu ZB, Ates O, Gocmen G. Traditional vs. orthodontic extraction of impacted teeth related to the inferior alveolar nerve: a randomized control trial. BMC Oral Health. 2025 Jul 2;25(1):1036. doi: 10.1186/s12903-025-06402-7.
PubMed 40604669
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve
- ClinicalTrials.gov ID
- NCT06270784
- Acronym / sponsor ID
- 09.2024.122
- Conditions
- Inferior Alveolar Nerve Injuries
- Keywords
- Mandibular nerve injuries, impacted teeth, tooth extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 21 Feb 2024 (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.
The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:
-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?
Participants will:
- undergo either traditional or orthodontic extraction
- be monitored for postoperative paresthesia.
Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage.
Detailed description
The extraction of an impacted mandibular third molar is one of the most frequently performed procedures by oral and maxillofacial surgeons. The close anatomical relationship between the root of an impacted mandibular third molar and the inferior alveolar nerve may result in inferior alveolar nerve damage. The incidence of inferior alveolar nerve injury during the removal of an impacted mandibular third molar ranges from 0.35% to 8.4%. In addition to radiographic analysis, various surgical techniques, such as coronectomy, have been proposed to reduce the incidence of inferior alveolar nerve injury.
The orthodontic extraction technique is an orthodontically supported surgical approach that reduces the risk of neurological complications that may occur in inferior alveolar nerve and facilitates the surgical removal of impacted mandibular third molars close to the mandibular canal, even if they are associated with cystic lesions.
The purpose of this study is to examine the effect of orthodontic extraction applied to minimize inferior alveolar nerve damage during the extraction of deeply impacted mandibular third molar teeth on postoperative nerve injury. For this purpose, the postoperative paresthesia findings of patients who underwent orthodontic extraction will be compared with those of those who underwent traditional extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Extraction Group | Active comparator | Procedure: Traditional Extraction |
| Orthodontic Extraction Group | Experimental | Procedure: Orthodontic Extraction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Presence of indication for wisdom tooth extraction for reasons such as pericoronitis, pathological formation, orthodontic reasons, caries, etc.
- Mandibular impacted wisdom teeth close to the inferior alveolar nerve
Key exclusion criteria (5 listed)
- Mandibular impacted wisdom tooth not close to inferior alveolar nerve
- Wisdom tooth whose apexification has not yet been completed
- Suspicion of a malignant pathological lesion
- Pathological lesion associated with inferior alveolar nerve
- Presence of an acute infection
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 |
|---|---|---|
| Traditional ExtractionParticipants in this group will undergo traditional extraction method. This method involves uncovering the impacted tooth and extracting the tooth with or without dividing it. | Procedure or surgery | Traditional Extraction Group |
| Orthodontic ExtractionParticipants in this group will undergo orthodontic extraction method. In this method, a two-stage surgical procedure will be performed. In the first operation, the impacted tooth will be uncovered, and then a button will be placed on the tooth. For anchorage purposes, orthodontic mini screws will be placed in the mandibular ramus or zygomaticomaxillary buttress area. Elastics and/or ligature wires fixed to the button will be attached to the mini screw to provide force for the traction of the tooth. Patients will be called for check-up appointments every two weeks, and the movement of the impacted tooth will be monitored with panoramic x-rays. The second operation will be planned when the tooth moves away from the inferior alveolar nerve. In the second operation, the tooth will be extracted in a similar way to the traditional extraction group. | Procedure or surgery | Orthodontic Extraction Group |
Primary outcome
2-point discrimination test on the 7th day after surgery
Time frame: A 2-point discrimination test will be performed before the extraction and 7 days after extraction in both groups.
The primary outcome measure of the study was the assessment of nerve injury. For this purpose, postoperative nerve injury will be recorded by a 2-point discrimination test with the help of a caliper with a 1mm gap.
3 secondary outcomes
Visual Analog Score(VAS)
Time frame: VAS will be evaluated on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.
2-point discrimination test on the 14th days and the 1st, 3rd, and 6th months after extraction.
Time frame: A 2-point discrimation test will be performed on the 14th days and the 1st, 3rd, and 6th months after extraction.
Inferior alveolar nerve recovery
Time frame: Inferior alveolar nerve recovery will be assessed on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.
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 7 May 2025.
- Derived from this study: PubMed 40604669Askin Ekinci S, Kiristioglu ZB, Ates O, Gocmen G. Traditional vs. orthodontic extraction of impacted teeth related to the inferior alveolar nerve: a randomized control trial. BMC Oral Health. 2025 Jul 2;25(1):1036. doi: 10.1186/s12903-025-06402-7.
- Individual participant dataSharing planned: No
Related trials for Inferior Alveolar Nerve Injuries
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Extraction and Orthodontic Extraction in people with Inferior Alveolar Nerve Injuries, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 7 May 2025. 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 Turkey (Türkiye). 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?
2-point discrimination test on the 7th day after surgery (time frame: A 2-point discrimination test will be performed before the extraction and 7 days after extraction in both groups.). 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 NCT06270784, which also lists 1 linked publication.
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 7 May 2025.