Clinical trial NCT05811741: Impact of Mandibular Canal Trajectory on Paresthesia After Inferior Alveolar Nerve Lateralization
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Bone Loss
Neurosensory Disorder
Keywords: Mandibular canal
Paresthesia
Dental implants
Survival analysis
Inferior alveolar nerve lateralization
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Light touch test results
timeFrame: Visits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery
measure: 2-point discrimination test results
timeFrame: isits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery.
Secondary outcomes:
measure: Thickness of the buccal cortex
timeFrame: At baseline
measure: Thickness of the mandibular inferior border
timeFrame: At baseline
measure: Diameter of the nerve canal
timeFrame: At baseline
measure: Distance from the nerve canal to the buccal cortex
timeFrame: At baseline
measure: Distance from the nerve canal to the inferior border of the mandible
timeFrame: At baseline
measure: Change in Implant stability quotient (ISQ) values:
timeFrame: During implant placement and follow-up visits at 3 months.
measure: Change in peri-implant bone resorption
timeFrame: At 3 months, and 12 months after surgery.
measure: Patient satisfaction
timeFrame: At 12 month follow-up visit
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
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