The Effect of Implant-supported Prosthesis on Acoustic Voice Quality

January 5, 2024 updated by: Ferit Bayram, Marmara University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34854
        • Recruiting
        • Marmara University School of Dentistry
        • Principal Investigator:
          • Ceren Küçük
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acoustic voice quality index
Time Frame: At the follow-up session (approximately one year after delivery of the prosthesis)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant success
Time Frame: At the follow-up session (approximately one year after delivery of the prosthesis)

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.
At the follow-up session (approximately one year after delivery of the prosthesis)
Prosthetic Success
Time Frame: At the follow-up session (approximately one year after delivery of the prosthesis)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUDHF_PTT_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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