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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05710484
Other study ID # MUDHF_FB_003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2023
Est. completion date August 15, 2023

Study information

Verified date September 2023
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 15, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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 (8)

Barsties V Latoszek B, Ulozaite-Staniene N, Petrauskas T, Uloza V, Maryn Y. Diagnostic Accuracy of Dysphonia Classification of DSI and AVQI. Laryngoscope. 2019 Mar;129(3):692-698. doi: 10.1002/lary.27350. Epub 2018 Sep 10. — View Citation

Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042. — View Citation

Correia JM, Caballero-Gaudes C, Guediche S, Carreiras M. Phonatory and articulatory representations of speech production in cortical and subcortical fMRI responses. Sci Rep. 2020 Mar 11;10(1):4529. doi: 10.1038/s41598-020-61435-y. — View Citation

Hogikyan ND, Sethuraman G. Validation of an instrument to measure voice-related quality of life (V-RQOL). J Voice. 1999 Dec;13(4):557-69. doi: 10.1016/s0892-1997(99)80010-1. — View Citation

Maryn Y, Corthals P, Van Cauwenberge P, Roy N, De Bodt M. Toward improved ecological validity in the acoustic measurement of overall voice quality: combining continuous speech and sustained vowels. J Voice. 2010 Sep;24(5):540-55. doi: 10.1016/j.jvoice.2008.12.014. Epub 2009 Nov 2. — View Citation

Nanjundeswaran C, Jacobson BH, Gartner-Schmidt J, Verdolini Abbott K. Vocal Fatigue Index (VFI): Development and Validation. J Voice. 2015 Jul;29(4):433-40. doi: 10.1016/j.jvoice.2014.09.012. Epub 2015 Mar 17. — View Citation

Sirin S, Ogut MF, Bilgen C. Reliability and validity of the Turkish version of the Vocal Fatigue Index. Turk J Med Sci. 2020 Jun 23;50(4):902-909. doi: 10.3906/sag-1908-105. — View Citation

Yesilli-Puzella G, Tadihan-Ozkan E, Maryn Y. Validation and Test-Retest Reliability of Acoustic Voice Quality Index Version 02.06 in the Turkish Language. J Voice. 2022 Sep;36(5):736.e25-736.e32. doi: 10.1016/j.jvoice.2020.08.021. Epub 2020 Sep 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Acoustic Voice Analyze measurements; Motor Speech Profile (MSP) 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
Primary Change in Acoustic Voice Analyze measurements; Multi-dimensional voice program (MDVP) 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
Primary Change in Acoustic Voice Analyze measurements; Analysis of dysphonia in speech and voice (ADSV) 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
Primary Change in Acoustic Voice Analyze measurements;Acoustic Voice Quality Index (AVQI) 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 Change in BORG Scale (CR-10) 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
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