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

Alveolar Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811741
• Other study ID #: MUDHF_FB_006
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Neurosensory Disorder
• Paresthesia

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Thickness of the buccal cortex	This outcome measure evaluates the thickness of the buccal cortex using radiographic measurements obtained from CBCT scans.	At baseline
Secondary	Thickness of the mandibular inferior border	This outcome measure evaluates the thickness of the mandibular inferior border using radiographic measurements obtained from CBCT scans.	At baseline
Secondary	Diameter of the nerve canal	This outcome measure evaluates the diameter of the nerve canal using radiographic measurements obtained from CBCT scans.	At baseline
Secondary	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.	At baseline
Secondary	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.	At baseline
Secondary	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.	During implant placement and follow-up visits at 3 months.
Secondary	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.	At 3 months, and 12 months after surgery.
Secondary	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.	At 12 month follow-up visit