NCT06270784

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

May 7, 2025

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

February 13, 2024

Last Update Submit

May 6, 2025

Conditions

Keywords

Mandibular nerve injuries, impacted teeth, tooth extraction

Outcome Measures

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.

    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)

    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.

    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

    Inferior alveolar nerve recovery will be assessed on the 7th and 14th postoperative days and the 1st, 3rd, and 6th months after tooth extraction.

Study Arms (2)

Traditional Extraction Group

ACTIVE COMPARATOR
Procedure: Traditional Extraction

Orthodontic Extraction Group

EXPERIMENTAL
Procedure: Orthodontic Extraction

Interventions

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.

Traditional Extraction Group

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.

Orthodontic Extraction Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Basibuyuk, 34854, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mandibular Nerve InjuriesTooth, Impacted

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

January 17, 2024

Primary Completion

May 6, 2024

Study Completion

November 6, 2024

Last Updated

May 7, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations