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Anesthesia, LocalNCT05710484

Voice Quality Changes With IANB Anesthesia

An observational study of Anesthesia, Local and Voice Change, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia, Local, Voice Change
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2023to 15 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Marmara University School of Dentistry

    Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Keywords
Voice Quality, Anesthesia, Dental, Mandibular Nerve, Lingual Nerve, Speech Acoustics
Medical subject headings
Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05710484
Study groupRoleWhat they receive
Inferior alveolar nerve block anesthesia cohortThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later

  2. 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/.

    Measured: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later

  3. 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.

    Measured: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later

  4. 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.

    Measured: Immediate before inferior alveolar nerve block anesthesia, immediately after inferior alveolar nerve block anesthesia roughly 5 minutes later

Secondary outcomes (1)

  1. 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.

    Measured: Exercise timing is immediate before inferior alveolar nerve block anesthesia, holding a dental mirror with only lips and tongue, for 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start15 Mar 2023
  3. Primary completion15 Jul 2023
  4. Study completion15 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05710484
Sponsor's protocol ID
MUDHF_FB_003
Status last verified
Sep 2023
First submitted
25 Jan 2023
Last updated
14 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30203473

  • 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.

    PubMed 18436027

  • 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.

    PubMed 32161310

  • 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.

    PubMed 10622521

  • 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.

    PubMed 19883993

  • 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.

    PubMed 25795356

  • 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.

    PubMed 32421276

  • 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.

    PubMed 32962941

  • Sahin C, Bayram F, Yilmaz G, Gocmen GB, Konrot A. Effect of inferior alveolar and lingual nerve block anesthesia on acoustic voice quality and speech effort: A within-subject study. J Am Dent Assoc. 2025 Dec;156(12):982-990. doi: 10.1016/j.adaj.2025.08.021. Epub 2025 Oct 14.

    PubMed 41085515

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, Local and Voice Change, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05710484, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.

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