NCT05692609

Brief Summary

The primary aim of this study was to compare the acoustic sound quality of edentulous patients rehabilitated with two-implant overdentures or the all-on-4 concept. The secondary aims were to evaluate the effect of implant and prosthetic success on acoustics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

January 11, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

Dental Prosthesis, Implant-SupportedSpeech Acoustics

Outcome Measures

Primary Outcomes (1)

  • Acoustic voice quality index

    The 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. Acoustic voice quality will be evaluated in accordance with the AVQI index. During the control session, two separate voice recordings will be made with and without the participants' dentures in the mouth and transferred to the software. The score obtained according to the AVQI index will be used for statistical analysis between groups.

    At the follow-up session (approximately one year after delivery of the prosthesis)

Secondary Outcomes (2)

  • Implant success

    At the follow-up session (approximately one year after delivery of the prosthesis)

  • Prosthetic Success

    At the follow-up session (approximately one year after delivery of the prosthesis)

Study Arms (2)

Implant overdenture group

In the control session, participants' acoustic sound quality, implant and prosthesis success will be measured.

All-on-4 group

In the control session, participants' acoustic sound quality, implant and prosthesis success will be measured.

Eligibility Criteria

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

Patients with all-on-4 or two-implant overdentures whose surgery and prosthesis were performed at Marmara University Faculty of Dentistry clinics

You may qualify if:

  • No voice disorder or speech therapy
  • The implant prosthesis was made at least one year ago, delivered to the patient, and continues to be used

You may not qualify if:

  • Smoking (\>10 cigarettes/day) or substance use
  • History of acute or chronic respiratory diseases
  • Overdenture prosthesis on three or 4 implants
  • History of speech and hearing problems
  • Patients who have lost any implants before the control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (17)

  • Tyrovolas S, Koyanagi A, Panagiotakos DB, Haro JM, Kassebaum NJ, Chrepa V, Kotsakis GA. Population prevalence of edentulism and its association with depression and self-rated health. Sci Rep. 2016 Nov 17;6:37083. doi: 10.1038/srep37083.

    PMID: 27853193BACKGROUND
  • Marcus PA, Joshi A, Jones JA, Morgano SM. Complete edentulism and denture use for elders in New England. J Prosthet Dent. 1996 Sep;76(3):260-6. doi: 10.1016/s0022-3913(96)90169-9.

    PMID: 8887798BACKGROUND
  • Romandini M, Baima G, Antonoglou G, Bueno J, Figuero E, Sanz M. Periodontitis, Edentulism, and Risk of Mortality: A Systematic Review with Meta-analyses. J Dent Res. 2021 Jan;100(1):37-49. doi: 10.1177/0022034520952401. Epub 2020 Aug 31.

    PMID: 32866427BACKGROUND
  • Nowjack-Raymer RE, Sheiham A. Association of edentulism and diet and nutrition in US adults. J Dent Res. 2003 Feb;82(2):123-6. doi: 10.1177/154405910308200209.

    PMID: 12562885BACKGROUND
  • Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014 Oct;93(10):959-65. doi: 10.1177/0022034514546165. Epub 2014 Aug 21.

    PMID: 25146182BACKGROUND
  • Douglass CW, Watson AJ. Future needs for fixed and removable partial dentures in the United States. J Prosthet Dent. 2002 Jan;87(1):9-14. doi: 10.1067/mpr.2002.121204.

    PMID: 11807477BACKGROUND
  • Malo P, Rangert B, Nobre M. "All-on-Four" immediate-function concept with Branemark System implants for completely edentulous mandibles: a retrospective clinical study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:2-9. doi: 10.1111/j.1708-8208.2003.tb00010.x.

    PMID: 12691645BACKGROUND
  • Zitzmann NU, Scharer P, Marinello CP. Factors influencing the success of GBR. Smoking, timing of implant placement, implant location, bone quality and provisional restoration. J Clin Periodontol. 1999 Oct;26(10):673-82. doi: 10.1034/j.1600-051x.1999.261007.x.

    PMID: 10522779BACKGROUND
  • Jacobs R, Manders E, Van Looy C, Lembrechts D, Naert I, van Steenberghe D. Evaluation of speech in patients rehabilitated with various oral implant-supported prostheses. Clin Oral Implants Res. 2001 Apr;12(2):167-73. doi: 10.1034/j.1600-0501.2001.012002167.x.

    PMID: 11251667BACKGROUND
  • Lu FL, Matteson S. Speech tasks and interrater reliability in perceptual voice evaluation. J Voice. 2014 Nov;28(6):725-32. doi: 10.1016/j.jvoice.2014.01.018. Epub 2014 May 17.

    PMID: 24841668BACKGROUND
  • Umapathy K, Krishnan S, Parsa V, Jamieson DG. Discrimination of pathological voices using a time-frequency approach. IEEE Trans Biomed Eng. 2005 Mar;52(3):421-30. doi: 10.1109/TBME.2004.842962.

    PMID: 15759572BACKGROUND
  • Asiaee M, Nourbakhsh M, Vahedian-Azimi A, Zare M, Jafari R, Atashi SS, Keramatfar A. The feasibility of using acoustic measures for predicting the Total Opacity Scores of chest computed tomography scans in patients with COVID-19. Clin Linguist Phon. 2024 Mar;38(2):97-115. doi: 10.1080/02699206.2022.2160659. Epub 2023 Jan 2.

    PMID: 36592050BACKGROUND
  • Shabnam S, Pushpavathi M, Gopi Sankar R, Sridharan KV, Vasanthalakshmi MS. A Comprehensive Application for Grading Severity of Voice Based on Acoustic Voice Quality Index v.02.03. J Voice. 2025 Jan;39(1):287.e1-287.e9. doi: 10.1016/j.jvoice.2022.08.013. Epub 2022 Oct 1.

    PMID: 36192290BACKGROUND
  • 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
  • Englert M, Barsties V Latoszek B, Maryn Y, Behlau M. Validation of the Acoustic Voice Quality Index, Version 03.01, to the Brazilian Portuguese Language. J Voice. 2021 Jan;35(1):160.e15-160.e21. doi: 10.1016/j.jvoice.2019.07.024. Epub 2019 Aug 29.

    PMID: 31474432BACKGROUND
  • Faham M, Laukkanen AM, Ikavalko T, Rantala L, Geneid A, Holmqvist-Jamsen S, Ruusuvirta K, Pirila S. Acoustic Voice Quality Index as a Potential Tool for Voice Screening. J Voice. 2021 Mar;35(2):226-232. doi: 10.1016/j.jvoice.2019.08.017. Epub 2019 Sep 30.

    PMID: 31582330BACKGROUND
  • 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

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

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

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations