Influence of Mandibular Nerve Lateralization on Nutrition and Speech

NCT05659069 | Active Not Recruiting

• 1 other identifier: MU_DHF_SBF_05
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of lip numbness on the nutritional status and speech of patients who underwent inferior nerve lateralization for dental implant placement in the mandibular posterior region. For this purpose, observational follow-up of two groups of patients will be performed. The control group will include patients with standard implant placement in the mandibular posterior region. The test group will consist of patients with implant placement in the mandibular posterior region with inferior alveolar nerve lateralization. The patients will be evaluated before implant surgery and followed up for four months until the final prosthesis is placed. Changes in nutritional status, masticatory performance and speech abilities will be assessed during this process.

Conditions

Alveolar Bone Loss; Bone Deformity

Keywords

Dental implants; Mandibular nerve; Nutritional status

Outcome Measures

Primary Outcomes (4)

• Change from baseline in a neurosensory disturbance with a two-point discrimination test

  Using a calliper, this test will be carried out. Care should be given to ensure that both calliper tips are touching the lower lip simultaneously until the patient can distinguish between two points of contact, at which point the distance between the two points is noted.

  Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change from baseline in lip sensitivity pattern with semmes-weinstein monofilament test

  Mapping of the Semmes-Weinstein monofilament pressure thresholds in the lower lip's predetermined regions.

  Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change from baseline in nutritional status

  The Subjective Global Assessment (SGA) will be used to assess changes in nutritional status. SGA is an easy-to-apply, a low-cost and reliable method frequently used to evaluate malnutrition status. After the patient is assessed according to specific criteria, the level of malnutrition is determined by the evaluator's subjective point of view. It is a four-part evaluation. These are weight loss and food intake history, gastrointestinal system symptoms, functional capacity, metabolic requirements, and physical examination. The analysis of the information and the results from it are scored as A, B, C. If the patient is well-nourished, he is classified as A, moderately malnourished, B, and severely malnourished, C. SGA will be applied by the researchers in face-to-face meetings.

  Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change in acoustic characteristics of speech

  PRAAT software will be used for scientific analysis of speech and phonetics. In our study, the acoustic properties of speech will be recorded and compared with the help of PRAAT before and after the implant, and it will be examined whether these properties have changed or not. Pitch characteristics, jitter values, shimmer values, intensities and speech breaks, if any, will be observed. Shimmer (dB): Shimmer is a parameter that shows the relative change between the sound wave amplitudes at short intervals. The peak amplitude of each period is compared with the peak amplitude of the next period, and shimmer can be calculated in dB. Jitter: Jitter is the parameter that shows the variability of the vibratory cycle frequency with respect to the subsequent cycle frequency.

  Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.

Secondary Outcomes (5)

• Change from baseline in the masticatory performance

  Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change from baseline in body weight

  Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change from baseline in food consumption

  Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change from baseline in depression test

  Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.

• Change from baseline in observational assessment of chewing

  Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.

Study Arms (2)

Control group

10 patients with dental implant placement without inferior alveolar nerve lateralization

Lateralization group

10 patients with dental implant placement with inferior alveolar nerve lateralization.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with missing teeth in the posterior mandibular region and planned dental implant construction will constitute the study population.

You may qualify if:

• A standard dental implant with or without lateralization of the inferior alveolar nerve in the posterior region of the mandible at the Marmara University Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery clinic.
• The patient accepted to participate in the study and gave written/verbal consent

You may not qualify if:

• Dental implant placement in the posterior region of the mandible with additional surgical methods (onlay/inlay graft, directed tissue regeneration, etc.) other than nerve lateralization.
• Patients had a neurosensory disorder in the maxillofacial region before implant surgery

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (17)

• Krekmanov L, Kahn M, Rangert B, Lindstrom H. Tilting of posterior mandibular and maxillary implants for improved prosthesis support. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):405-14.

  PMID: 10874806 BACKGROUND

• de Vicente JC, Pena I, Brana P, Hernandez-Vallejo G. The use of piezoelectric surgery to lateralize the inferior alveolar nerve with simultaneous implant placement and immediate buccal cortical bone repositioning: a prospective clinical study. Int J Oral Maxillofac Surg. 2016 Jul;45(7):851-7. doi: 10.1016/j.ijom.2016.01.017. Epub 2016 Feb 17.

  PMID: 26897328 BACKGROUND

• Abayev B, Juodzbalys G. Inferior alveolar nerve lateralization and transposition for dental implant placement. Part I: a systematic review of surgical techniques. J Oral Maxillofac Res. 2015 Mar 30;6(1):e2. doi: 10.5037/jomr.2014.6102. eCollection 2015 Jan-Mar.

  PMID: 25937873 BACKGROUND

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

  PMID: 265383 BACKGROUND

• Deryabin G, Grybauskas S. Dental implant placement with inferior alveolar nerve repositioning in severely resorbed mandibles: a retrospective multicenter study of implant success and survival rates, and lower lip sensory disturbances. Int J Implant Dent. 2021 Jun 9;7(1):44. doi: 10.1186/s40729-021-00334-x.

  PMID: 34105021 BACKGROUND

• Khojasteh A, Hassani A, Motamedian SR, Saadat S, Alikhasi M. Cortical Bone Augmentation Versus Nerve Lateralization for Treatment of Atrophic Posterior Mandible: A Retrospective Study and Review of Literature. Clin Implant Dent Relat Res. 2016 Apr;18(2):342-59. doi: 10.1111/cid.12317. Epub 2015 Jun 17.

  PMID: 26082191 BACKGROUND

• Vetromilla BM, Moura LB, Sonego CL, Torriani MA, Chagas OL Jr. Complications associated with inferior alveolar nerve repositioning for dental implant placement: a systematic review. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1360-6. doi: 10.1016/j.ijom.2014.07.010. Epub 2014 Aug 12.

  PMID: 25128261 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

• Hirsch JM, Branemark PI. Fixture stability and nerve function after transposition and lateralization of the inferior alveolar nerve and fixture installation. Br J Oral Maxillofac Surg. 1995 Oct;33(5):276-81. doi: 10.1016/0266-4356(95)90037-3.

  PMID: 8555142 BACKGROUND

• Lin CS, Wu SY, Huang HY, Lai YL. Systematic Review and Meta-Analysis on Incidence of Altered Sensation of Mandibular Implant Surgery. PLoS One. 2016 Apr 21;11(4):e0154082. doi: 10.1371/journal.pone.0154082. eCollection 2016.

  PMID: 27100832 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

• Tomazi MA, da Silveira Gerzson A, Neto AM, da Costa ALP. In-Block Lateralization as a New Technique for Mobilization of the Inferior Alveolar Nerve: A Technique Case Series. J Oral Implantol. 2021 Aug 1;47(4):333-341. doi: 10.1563/aaid-joi-D-20-00041.

  PMID: 32838423 BACKGROUND

• Fernandez Diaz JO, Naval Gias L. Rehabilitation of edentulous posterior atrophic mandible: inferior alveolar nerve lateralization by piezotome and immediate implant placement. Int J Oral Maxillofac Surg. 2013 Apr;42(4):521-6. doi: 10.1016/j.ijom.2012.10.015. Epub 2012 Nov 12.

  PMID: 23153786 BACKGROUND

• Hassani A, Saadat S, Moshiri R, Shahmirzad S, Hassani A. Nerve Retraction During Inferior Alveolar Nerve Repositioning Procedure: A New Simple Method and Review of the Literature. J Oral Implantol. 2015 Jul;41 Spec No:391-4. doi: 10.1563/AAID-JOI-D-13-00108. Epub 2013 Dec 17.

  PMID: 24344674 BACKGROUND

• Renton T, Dawood A, Shah A, Searson L, Yilmaz Z. Post-implant neuropathy of the trigeminal nerve. A case series. Br Dent J. 2012 Jun 8;212(11):E17. doi: 10.1038/sj.bdj.2012.497.

  PMID: 22677874 BACKGROUND

• Renton T, Yilmaz Z. Profiling of patients presenting with posttraumatic neuropathy of the trigeminal nerve. J Orofac Pain. 2011 Fall;25(4):333-44.

  PMID: 22247929 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 21, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TU (1)