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Edentulous JawNCT05692609

The Effect of Implant-supported Prosthesis on Acoustic Voice Quality

An observational study of Edentulous Jaw, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Edentulous Jaw
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2023to 1 Jun 2024
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: Patients with all-on-4 or two-implant overdentures whose surgery and prosthesis were performed at Marmara University Faculty of Dentistry clinics

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting

  • Marmara University School of Dentistry

    Istanbul, 34854

    Ferit Bayram, Ph. D., 2167775074, ferit.bayram@marmara.edu.tr

    Ceren Küçük

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Acoustic Voice Quality of Edentulous Patients Treated With Two-implant Overdentures or All-on-4 Concept

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.

Conditions
Edentulous Jaw
Keywords
Dental Prosthesis, Implant-Supported, Speech Acoustics
Medical subject headings
Jaw, Edentulous

What participants receive

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

Study groups in NCT05692609
Study groupRoleWhat they receive
Implant overdenture groupIn the control session, participants' acoustic sound quality, implant and prosthesis success will be measured.
All-on-4 groupIn the control session, participants' acoustic sound quality, implant and prosthesis success will be measured.

What is being measured

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

  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.

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

Secondary outcomes (2)

  1. Implant success

    Implant success will be defined according to the following criteria:

    • Clinical stability and immobility (0); (1)
    • Full functionality (0); (1)
    • Absence of pain on mild percussion (0); (1)
    • Healthy peri-implant soft tissue and radiolucency at probing (0); (1)
    • Absence of other radiographic pathologic conditions (0); (1). Implant loss and implant mobility will be recorded on standardized documentation forms, as will complications related to prostheses.

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

  2. Prosthetic Success

    The success of the prosthetic treatment will be evaluated according to the criteria set by Awad and Feine. Participants will be asked about their overall satisfaction with their prosthesis. Also;

    • Prosthesis stability (0) - (10)
    • Comfort (0) - (10)
    • Chewing skills (0) - (10)
    • Speaking skills (0) - (10)
    • Ease of cleaning (0) - (10) and
    • They will be asked to rate their aesthetic appearance (Awad \& Feine, 1998).

    Participants will rate each item on a 10 cm visual analog scale, where the anchor words are "not at all satisfied" for zero and "completely satisfied" for 10. Participants will be asked to draw a vertical line at the point on the scale that best reflects their responses, where higher scores indicate greater satisfaction.

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

Timeline

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

  1. First posted20 Jan 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692609
Sponsor's protocol ID
MUDHF_PTT_02
Status last verified
Jan 2024
First submitted
11 Jan 2023
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27853193

  • 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.

    PubMed 8887798

  • 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.

    PubMed 32866427

  • 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.

    PubMed 12562885

  • 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.

    PubMed 25146182

  • 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.

    PubMed 11807477

  • 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.

    PubMed 12691645

  • 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.

    PubMed 10522779

  • 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.

    PubMed 11251667

  • 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.

    PubMed 24841668

  • 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.

    PubMed 15759572

  • 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.

    PubMed 36592050

  • 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.

    PubMed 36192290

  • 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

  • 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.

    PubMed 31474432

Questions about this trial

What is this clinical trial studying?

An observational study of Edentulous Jaw, 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acoustic voice quality index (time frame: At the follow-up session (approximately one year after delivery of the prosthesis)). 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 NCT05692609, which also lists 17 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 8 Jan 2024.

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