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

Completed
Conditions
Alveolar Bone Loss
Neurosensory Disorder
Registration Number
NCT05811741
Lead Sponsor
Marmara University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Light touch test resultsVisits 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-point discrimination test resultsisits 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 Outcome Measures
NameTimeMethod
Diameter of the nerve canalAt baseline

This outcome measure evaluates the diameter of the nerve canal using radiographic measurements obtained from CBCT scans.

Distance from the nerve canal to the inferior border of the mandibleAt 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.

Thickness of the mandibular inferior borderAt baseline

This outcome measure evaluates the thickness of the mandibular inferior border using radiographic measurements obtained from CBCT scans.

Thickness of the buccal cortexAt baseline

This outcome measure evaluates the thickness of the buccal cortex using radiographic measurements obtained from CBCT scans.

Distance from the nerve canal to the buccal cortexAt baseline

This outcome measure evaluates the distance from the nerve canal to the buccal cortex using radiographic measurements obtained from CBCT scans.

Change in peri-implant bone resorptionAt 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.

Change in Implant stability quotient (ISQ) values: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.

Patient satisfactionAt 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.

Trial Locations

Locations (1)

Marmara University School of Dentistry

🇹🇷

Istanbul, Turkey

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