Influence of Mandibular Nerve Lateralization on Nutrition and Speech

Alveolar Bone Loss Clinical Trial

Official title:

The Effect of Inferior Alveolar Nerve Lateralization on Nutritional Status, Masticatory Performance and Speech; Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05659069
• Other study ID #: MU_DHF_SBF_05
• Status: Active, not recruiting
• Start date: February 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Deformity

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 (17)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Change from baseline in the masticatory performance	The masticatory performance of patients at the baseline, one month and six months later will be taken with a colour-changeable gum called "XYLITOL" (70x20x1 mm 3 g; Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan). Colour-changeable gum was first developed to evaluate a person's masticatory performance, changing colour as it is chewed. The gum will be chewed 60 times by the TMD patients. These values will be recorded and compared with the baseline, 1, 2, 3, and 4 months. After chewing, the gum colour will be evaluated according to the improved colour scale. The Colour scale ranges from 1-10, and the masticatory performance will be assessed as poor (1-6), average (7-8), or reasonable (9-10) with the improved colour scale.	Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Secondary	Change from baseline in body weight	Body weight will be evaluated during face-to-face interviews with patients in baseline, 1, 2, 3, and 4 months with the Tanita DC-360 body analyser. Patients will be asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.) and any heavy clothing, shoes, or socks before stepping on the device. The device was set to -1.0 kg for the remaining clothes.	Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Secondary	Change from baseline in food consumption	To evaluate the food consumption of the patients included in the study, at the baseline, 1, 2, 3, and 4 months will be taken with the 24-hour recall method. The amount of nutrients included in the meals will be calculated by using the "Standard Recipes" book, and the measurement amounts will be calculated by using the "Food Photo Catalogue" book. The data obtained from the 24-hour recall method will be analyzed using the "Computer Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS)", and the amount of energy, carbohydrates, protein, fat, fiber and micronutrients consumed by participants will be calculated. Intake of energy, macronutrients, fiber and micronutrients will be compared with baseline evaluation followed by reevaluations.	Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Secondary	Change from baseline in depression test	Beck Depression Scale will be used for the evaluation of depression status. The scale consists of 21 items. Two items are divided into emotions, eleven into cognitions, two into behaviours, five into physical symptoms, and one into interpersonal symptoms. Patients will be asked to choose the most appropriate question for their situation. Each question will be scored as 0, 1, 2, or 3, and scores ranging from 0-63 will be obtained. The results will be evaluated as 0-9 none/minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.	Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Secondary	Change from baseline in observational assessment of chewing	Fried pieces of meat, fried chicken, peeled apples, raw carrots, almonds, hazelnuts, slices of chocolate, bread, pasta, rice, feta cheese, meatballs, boiled carrots, and boiled vegetables prepared with the same standard procedures for each patient will be presented to the patients, and their chewing will be video recorded. It will be taken. Three different researchers evaluated the video recordings; They will be categorised as (I) hard to chew, (II) slightly hard to chew, and (III) easy to chew.	Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.