Influence of Mandibular Nerve Lateralization on Nutrition and Speech

March 11, 2024 updated by: Ferit Bayram, Marmara University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - Istanbul, Turkey, 34854
    - Marmara University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in a neurosensory disturbance with a two-point discrimination test Time Frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.	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 Time Frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.	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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MU_DHF_SBF_05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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