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CompletedNCT06270784Updated May 7, 2025

Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve

An interventional study of Traditional Extraction and Orthodontic Extraction in Inferior Alveolar Nerve Injuries, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Inferior Alveolar Nerve Injuries

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Keywords

  • Mandibular nerve injuries, impacted teeth, tooth extraction
03

In context

Tooth, Impacted

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Traditional Extraction Group

    Procedure: Traditional Extraction

  • Experimental
    Orthodontic Extraction Group

    Procedure: Orthodontic Extraction

Interventions

  • ProcedureTraditional Extraction

    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.

  • ProcedureOrthodontic Extraction

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: A 2-point discrimination test will be performed before the extraction and 7 days after extraction in both groups.

Secondary outcomes

  1. 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.

    Time frame: VAS will be evaluated on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.

  2. 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.

    Time frame: A 2-point discrimation test will be performed on the 14th days and the 1st, 3rd, and 6th months after extraction.

  3. 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.

    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.

07

Study locations

1 site
  • Marmara University
    Istanbul, Basibuyuk 34854, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in May 2024, 3 months.

Of 55 non-industry interventional studies with no phase under Tooth, Impacted, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 3 months is below that.

Counting every sponsor, half of 56 studies reached it within 20 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2024
First posted
Feb 21, 2024
StartActual
Jan 17, 2024
Primary completionActual
May 6, 2024
CompletionActual
Nov 6, 2024
Last update
May 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06270784
Lead sponsor
Marmara University
Responsible party
Senem Askin Ekinci (Principal Investigator, Marmara University) — Principal investigator
First posted
Feb 21, 2024
Start date
Jan 17, 2024
Primary completion
May 6, 2024
Completion
Nov 6, 2024
Last update
May 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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