Influence of Mandibular Nerve Lateralization on Nutrition and Speech

Study Overview
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Brief Summary
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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.

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

Conditions
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Alveolar Bone Loss, Bone Deformity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>10 patients with dental implant placement without inferior alveolar nerve lateralization | |
| Lateralization group<br>10 patients with dental implant placement with inferior alveolar nerve lateralization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Mandibular nerve, Nutritional status