Voice Quality Changes With IANB Anesthesia

September 13, 2023 updated by: Ferit Bayram, Marmara University

Investigating the Impact of Inferior Alveolar Nerve Block Anesthesia on Acoustic Voice Quality Using a Within-subject Design

Background: Inferior alveolar nerve block anesthesia is commonly used in dental procedures, but its effect on the voice quality is not well understood. The aim of this study is to investigate the effect of mandibular anesthesia on the acoustic voice quality index.

Objective: The primary objective of this study is to determine the effect of mandibular anesthesia on the acoustic voice quality index.

Design: This is a within-subject study design. Participants will be recruited from a local dental clinic and will be adults aged 18 years or older. The participants will have the acoustic voice quality index measured before and after the administration of mandibular anesthesia. The parameters that will be measured include acoustic voice quality index and self ........ The data will be analyzed using appropriate statistical techniques.

Expected Outcome: The study is expected to provide insights into the effect of mandibular anesthesia on the acoustic voice quality index. The results of this study may help in understanding the impact of mandibular anesthesia on voice quality and may have implications for dental practitioners and patients who receive mandibular anesthesia.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

34

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

Yes

Sampling Method

Probability Sample

Study Population

The study population will consist of adults aged 18 years or older who are scheduled to receive inferior alveolar nerve block anesthesia as part of their dental procedure.

Description

Inclusion Criteria:

  • able to provide informed consent
  • able to communicate in the local language
  • no history of voice disorders or speech therapy
  • no history of any diseases or conditions that could affect voice quality.

Exclusion Criteria:

  • pregnant or breastfeeding women
  • individuals with a history of allergies or adverse reactions to anesthesia
  • individuals with a history of any diseases or conditions that could affect voice quality

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

Cohorts and Interventions

Group / Cohort
Inferior alveolar nerve block anesthesia cohort
This group will consist of participants who are undergoing procedures that require mandibular anesthesia as routine part of care. Participants in this group will have voice recordings taken before and after the administration of anesthesia. The aim is to assess any changes in voice characteristics attributable to the effect of the anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Acoustic Voice Analyze measurements; Motor Speech Profile (MSP)
Time Frame: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Motor Speech Profile (MSP), is being used for accuracy and straightness of motor performance of speech. An inaccurate, inconsistent or abnormal oral-diadochokinetic performance may indicate disturbances in central nervous system or peripheral sensory motor functions. The software based on different protocols that provide different motor speech patterns such as oral diadochokinetic (DDK) rate, second formant transition rate, and syllable rate.
Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Change in Acoustic Voice Analyze measurements; Multi-dimensional voice program (MDVP)
Time Frame: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Multi-dimensional voice program (MDVP), basically, it is a computer program which analyzes various aspects of voice. It can provide many of acoustic parameters from a voice sample. It is based on a continuous vowel: /a/.
Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Change in Acoustic Voice Analyze measurements; Analysis of dysphonia in speech and voice (ADSV)
Time Frame: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Analysis of dysphonia in speech and voice (ADSV), evaluates frequency domain parameters. It is based on 2 different vowels ((/a/ and /i/) from Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and 6 different sentences. Every single sentence provides different voice analyses such as, containing all the vowels, making sounds with or without glottal attack, nasal sounds or explosive sounds.
Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Change in Acoustic Voice Analyze measurements;Acoustic Voice Quality Index (AVQI)
Time Frame: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later
Acoustic Voice Quality Index (AVQI), measures the perceived quality of a voice signal. It is based on evaluating several acoustic parameters that are known to be related to the perceived quality of speech. These parameters include measures of loudness, pitch and spectral tilt as well as measures of the presence of noise and other distortions in the signal.
Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BORG Scale (CR-10)
Time Frame: Exercise timing is immediate before inferior alveolar nerve block anesthesia, holding a dental mirror with only lips and tongue, for 2 minutes
A method for rating perceived effort and the CR-10 is a "semi-public/semi-public" tool for different boundaries and different measured structures. It is required for participants to correctly score the perceived effort against the variable during the experimental procedure. An exercise can be planned for setting the extreme points of the experience.
Exercise timing is immediate before inferior alveolar nerve block anesthesia, holding a dental mirror with only lips and tongue, for 2 minutes

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)

March 15, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUDHF_FB_003

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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