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NCT Number: NCT05811741

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

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.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neurosensory Disorder Paresthesia Pathological Conditions, Signs and Symptoms Periodontal Atrophy Periodontal Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Apr 13, 2023
Registry last updated
Jul 10, 2023

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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