ClinicalTrials.gg
CompletedNCT05811741Updated Jul 10, 2023

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

An observational study in Alveolar Bone Loss and Neurosensory Disorder, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Marmara University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alveolar Bone Loss
  • Neurosensory Disorder

Keywords

  • Mandibular canal
  • Paresthesia
  • Dental implants
  • Survival analysis
  • Inferior alveolar nerve lateralization
03

In context

Alveolar Bone Loss

318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

This study's enrollment of 20 is below the median of 51 across 46 observational studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for implant surgery

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Light touch test results

    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.

    Time frame: Visits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery

  2. 2-point discrimination test results

    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.

    Time frame: isits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery.

Secondary outcomes

  1. Thickness of the buccal cortex

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

    Time frame: At baseline

  2. Thickness of the mandibular inferior border

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

    Time frame: At baseline

  3. Diameter of the nerve canal

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

    Time frame: At baseline

  4. Distance from the nerve canal to the buccal cortex

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

    Time frame: At baseline

  5. Distance from the nerve canal to the inferior border of the mandible

    This outcome measure evaluates the distance from the nerve canal to the inferior border of the mandible using radiographic measurements obtained from CBCT scans.

    Time frame: At baseline

  6. Change in Implant stability quotient (ISQ) values:

    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.

    Time frame: During implant placement and follow-up visits at 3 months.

  7. Change in peri-implant bone resorption

    This outcome measure evaluates peri-implant bone resorption using OPTG. The amount of bone loss around the implant will be assessed and recorded.

    Time frame: At 3 months, and 12 months after surgery.

  8. Patient satisfaction

    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.

    Time frame: At 12 month follow-up visit

07

Study locations

1 site
  • Marmara University School of Dentistry
    Istanbul, 34854, Turkey
08

References and documents

Publications

  • Jung RE, Al-Nawas B, Araujo M, Avila-Ortiz G, Barter S, Brodala N, Chappuis V, Chen B, De Souza A, Almeida RF, Fickl S, Finelle G, Ganeles J, Gholami H, Hammerle C, Jensen S, Jokstad A, Katsuyama H, Kleinheinz J, Kunavisarut C, Mardas N, Monje A, Papaspyridakos P, Payer M, Schiegnitz E, Smeets R, Stefanini M, Ten Bruggenkate C, Vazouras K, Weber HP, Weingart D, Windisch P. Group 1 ITI Consensus Report: The influence of implant length and design and medications on clinical and patient-reported outcomes. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:69-77. doi: 10.1111/clr.13342. PubMed 30328189 ↗
  • Alling CC. Lateral repositioning of inferior alveolar neurovascular bundle. J Oral Surg. 1977 May;35(5):419. No abstract available. PubMed 265383 ↗
  • Jensen O, Nock D. Inferior alveolar nerve repositioning in conjunction with placement of osseointegrated implants: a case report. Oral Surg Oral Med Oral Pathol. 1987 Mar;63(3):263-8. doi: 10.1016/0030-4220(87)90187-3. PubMed 3473351 ↗
  • Lorean A, Kablan F, Mazor Z, Mijiritsky E, Russe P, Barbu H, Levin L. Inferior alveolar nerve transposition and reposition for dental implant placement in edentulous or partially edentulous mandibles: a multicenter retrospective study. Int J Oral Maxillofac Surg. 2013 May;42(5):656-9. doi: 10.1016/j.ijom.2013.01.020. Epub 2013 Mar 6. PubMed 23481542 ↗
  • Palacio Garcia-Ochoa A, Perez-Gonzalez F, Negrillo Moreno A, Sanchez-Labrador L, Cortes-Breton Brinkmann J, Martinez-Gonzalez JM, Lopez-Quiles Martinez J. Complications associated with inferior alveolar nerve reposition technique for simultaneous implant-based rehabilitation of atrophic mandibles. A systematic literature review. J Stomatol Oral Maxillofac Surg. 2020 Sep;121(4):390-396. doi: 10.1016/j.jormas.2019.12.010. Epub 2020 Jan 2. PubMed 31904530 ↗
  • Kan JY, Lozada JL, Goodacre CJ, Davis WH, Hanisch O. Endosseous implant placement in conjunction with inferior alveolar nerve transposition: an evaluation of neurosensory disturbance. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):463-71. PubMed 9274075 ↗
  • Abayev B, Juodzbalys G. Inferior Alveolar Nerve Lateralization and Transposition for Dental Implant Placement. Part II: a Systematic Review of Neurosensory Complications. J Oral Maxillofac Res. 2015 Mar 30;6(1):e3. doi: 10.5037/jomr.2014.6103. eCollection 2015 Jan-Mar. PubMed 25937874 ↗
  • Lee JH, Son YJ, Hwang JH, Baek SH, Jeon JH. Influence of anatomic position and intraoperative exposure of the inferior alveolar nerve on neurosensory disturbance after sagittal split ramus osteotomy: a three-dimensional computed tomography study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Sep;122(3):300-5. doi: 10.1016/j.oooo.2016.04.008. Epub 2016 Apr 23. PubMed 27373586 ↗
  • Rathod M, Kshirsagar RA, Joshi S, Pawar S, Tapadiya V, Gupta S, Mahajan V. Evaluation of Neurosensory Function Following Inferior Alveolar Nerve Lateralization for Implant Placement. J Maxillofac Oral Surg. 2019 Jun;18(2):273-279. doi: 10.1007/s12663-018-1124-1. Epub 2018 Jun 2. PubMed 30996551 ↗
  • Zarb GA, Albrektsson T. Consensus report: towards optimized treatment outcomes for dental implants. J Prosthet Dent. 1998 Dec;80(6):641. doi: 10.1016/s0022-3913(98)70048-4. No abstract available. PubMed 9830066 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05811741
Lead sponsor
Marmara University
Responsible party
Ferit Bayram (Assist. Prof., Marmara University) — Principal investigator
First posted
Apr 13, 2023
Start date
Jun 1, 2016
Primary completion
Dec 1, 2021
Completion
Apr 1, 2022
Last update
Jul 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion