Impact of Mandibular Canal Trajectory on Paresthesia After Inferior Alveolar Nerve Lateralization

July 7, 2023 updated by: Ferit Bayram, Marmara University

Evaluating the Influence of Mandibular Canal Trajectory on the Duration of Postoperative Paresthesia in Patients Undergoing Inferior Alveolar Nerve Lateralization: A Prospective Cohort Study

This prospective cohort study aims to investigate the relationship between mandibular canal trajectory and the duration of postoperative paresthesia in patients undergoing inferior alveolar nerve lateralization. The study will assess mandibular canal trajectory using anatomic factors and evaluate nerve sensory function using subjective and objective tests. Implant success criteria will also be assessed. The study will be conducted on patients who underwent IANL due to mandibular atrophy and were unable to receive standard or short implant placement. Data will be collected at regular follow-up visits up to 1-year post-surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of consecutive patients who were treated with inferior alveolar nerve lateralization (IANL) at Marmara University Faculty of Dentistry between June 2016 and December 2022. The patients had missing teeth in the posterior region of the mandible, in whom standard or short implant placement was not possible due to mandibular atrophy.

Description

Inclusion Criteria:

  • Patients with atrophied posterior mandible with less than or equal to 6 mm of bone over the inferior alveolar canal
  • No previous grafting or implant surgery at the site where nerve lateralization is planned
  • No neurosensory impairment
  • No contra-indications for implant surgery

Exclusion Criteria:

  • Patients who have undergone radiotherapy in the associated area
  • Patients using bone-modifying agents
  • Smokers with daily consumption of more than ten cigarettes
  • Patients with neurosensory impairment due to trauma, tumor, or cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light touch test results
Time Frame: Visits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery
The light touch test is a common diagnostic tool used to assess sensory perception. Patients' lower lip and chin areas will be gently stroked with a soft object, such as a piece of cotton or a brush. The patients will then be asked to report their sensation. If they feel the touch, the response is considered normal. However, any reported changes, such as numbness or tingling, can indicate possible nerve damage or recovery after surgery.
Visits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery
2-point discrimination test results
Time Frame: isits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery.
The 2-point discrimination test is a neurological examination used to measure tactile spatial acuity. Two points of a caliper will be applied to the patients' lower lip and chin areas. The distance at which a patient can no longer differentiate between the two points provides an indicator of sensory nerve function. Any reported changes in the ability to distinguish between two points may suggest alterations in nerve sensitivity or recovery after surgery.
isits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Implant stability quotient (ISQ) values:
Time Frame: During implant placement and follow-up visits at 3 months.
The Implant Stability Quotient (ISQ) is a metric ranging from 1 to 100 that is used to assess implant stability within the bone, with higher values indicating greater stability. To determine ISQ values, resonance frequency analysis (RFA) or sound waves are passed through a specialized peg attached to the implant.
During implant placement and follow-up visits at 3 months.
Change in peri-implant bone resorption
Time Frame: At 3 months, and 12 months after surgery.
This outcome measure evaluates peri-implant bone resorption using OPTG. The amount of bone loss around the implant will be assessed and recorded.
At 3 months, and 12 months after surgery.
Patient satisfaction
Time Frame: At 12 month follow-up visit
This outcome measure assesses patient satisfaction using a visual analog scale. Patients will be asked to rate their satisfaction with the treatment outcome at the 12-month follow-up visit.
At 12 month follow-up visit
Thickness of the buccal cortex
Time Frame: At baseline
This outcome measure evaluates the thickness of the buccal cortex using radiographic measurements obtained from CBCT scans.
At baseline
Thickness of the mandibular inferior border
Time Frame: At baseline
This outcome measure evaluates the thickness of the mandibular inferior border using radiographic measurements obtained from CBCT scans.
At baseline
Diameter of the nerve canal
Time Frame: At baseline
This outcome measure evaluates the diameter of the nerve canal using radiographic measurements obtained from CBCT scans.
At baseline
Distance from the nerve canal to the buccal cortex
Time Frame: At baseline
This outcome measure evaluates the distance from the nerve canal to the buccal cortex using radiographic measurements obtained from CBCT scans.
At baseline
Distance from the nerve canal to the inferior border of the mandible
Time Frame: At baseline
This outcome measure evaluates the distance from the nerve canal to the inferior border of the mandible using radiographic measurements obtained from CBCT scans.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

April 1, 2023

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUDHF_FB_006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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