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Completed

NCT Number: NCT06270784

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

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.

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Key information

Conditions

Inferior Alveolar Nerve Injuries Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Facial Nerve Diseases Facial Neuralgia Mandibular Nerve Injuries Mouth Diseases Nervous System Diseases Stomatognathic Diseases Tooth Diseases Tooth, Impacted Trauma, Nervous System Trigeminal Nerve Diseases Trigeminal Nerve Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Basibuyuk, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Traditional Extraction

Procedure

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 Extraction

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    Nerve injury will be recorded by a 2-point discrimination test with the help of a caliper with a 1mm gap.

  3. 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.

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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