The Effect of Implant-supported Prosthesis on Acoustic Voice Quality

Recruiting

• Conditions: Edentulous Jaw

• Registration Number: NCT05692609
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-03-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acoustic voice quality index	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.

Secondary Outcome Measures

Name	Time	Method
Implant success	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.
Prosthetic Success	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.

Trial Locations

Locations (1)

Marmara University School of Dentistry; 🇹🇷 Istanbul, Turkey