NCT05710484

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

January 25, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

Voice QualityAnesthesia, DentalMandibular NerveLingual NerveSpeech Acoustics

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Change in BORG Scale (CR-10)

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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 30203473BACKGROUND
  • 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.

    PMID: 18436027BACKGROUND
  • 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.

    PMID: 32161310BACKGROUND
  • 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.

    PMID: 10622521BACKGROUND
  • 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.

    PMID: 19883993BACKGROUND
  • 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.

    PMID: 25795356BACKGROUND
  • 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.

    PMID: 32421276BACKGROUND
  • 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.

    PMID: 32962941BACKGROUND
  • 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.

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 2, 2023

Study Start

March 15, 2023

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations