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

NCT05811741 | Completed

• 1 other identifier: MUDHF_FB_006
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss; Neurosensory Disorder

Keywords

Mandibular canal; Paresthesia; Dental implants; Survival analysis; Inferior alveolar nerve lateralization

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (8)

• Thickness of the buccal cortex

  At baseline

• Thickness of the mandibular inferior border

  At baseline

• Diameter of the nerve canal

  At baseline

• Distance from the nerve canal to the buccal cortex

  At baseline

• Distance from the nerve canal to the inferior border of the mandible

  At baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 30328189 BACKGROUND

• Alling CC. Lateral repositioning of inferior alveolar neurovascular bundle. J Oral Surg. 1977 May;35(5):419. No abstract available.

  PMID: 265383 BACKGROUND

• 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.

  PMID: 3473351 BACKGROUND

• 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.

  PMID: 23481542 BACKGROUND

• 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.

  PMID: 31904530 BACKGROUND

• 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.

  PMID: 9274075 BACKGROUND

• 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.

  PMID: 25937874 BACKGROUND

• 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.

  PMID: 27373586 BACKGROUND

• 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.

  PMID: 30996551 BACKGROUND

• 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.

  PMID: 9830066 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss; Sensation Disorders; Paresthesia

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 13, 2023
• Study Start: June 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

TU (1)