The Effect of Implant-supported Prosthesis on Acoustic Voice Quality

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692609
• Other study ID #: MUDHF_PTT_02
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous
• Mouth, Edentulous

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (17)

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. 2023 Jan 2:1-19. doi: 10.1080/02699206.2022.2160659. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2022 Sep 30:S0892-1997(22)00245-4. doi: 10.1016/j.jvoice.2022.08.013. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At the follow-up session (approximately one year after delivery of the prosthesis)
Secondary	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.	At the follow-up session (approximately one year after delivery of the prosthesis)