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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05675566
Other study ID # MUDHF_PTT_01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 1, 2024

Study information

Verified date March 2024
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at Marmara University Faculty of Dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 1, 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria: - 50-65 years old, - Volunteer to participate in the study, - Upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture Exclusion Criteria: - Pregnant or lactating women - Those who do not want to sign the consent form, - Patients with a history of malignancy, radiotherapy, or chemotherapy - Patients whose maxilla was rehabilitated with implant overdenture - More than 2 implants for lower jaw implant overdenture

Study Design


Related Conditions & MeSH terms


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 (7)

Akoglu B, Ucankale M, Ozkan Y, Kulak-Ozkan Y. Five-year treatment outcomes with three brands of implants supporting mandibular overdentures. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):188-94. — View Citation

Cousson PY, Bessadet M, Nicolas E, Veyrune JL, Lesourd B, Lassauzay C. Nutritional status, dietary intake and oral quality of life in elderly complete denture wearers. Gerodontology. 2012 Jun;29(2):e685-92. doi: 10.1111/j.1741-2358.2011.00545.x. Epub 2011 Oct 17. — View Citation

Evtimovska E, Masri R, Driscoll CF, Romberg E. The change in retentive values of locator attachments and hader clips over time. J Prosthodont. 2009 Aug;18(6):479-83. doi: 10.1111/j.1532-849X.2009.00474.x. Epub 2009 Jun 3. — View Citation

Fromentin O, Lassauzay C, Abi Nader S, Feine J, de Albuquerque Junior RF. Testing the retention of attachments for implant overdentures - validation of an original force measurement system. J Oral Rehabil. 2010 Jan;37(1):54-62. doi: 10.1111/j.1365-2842.2009.02020.x. Epub 2009 Nov 11. — View Citation

Sultana N, Bartlett DW, Suleiman M. Retention of implant-supported overdentures at different implant angulations: comparing Locator and ball attachments. Clin Oral Implants Res. 2017 Nov;28(11):1406-1410. doi: 10.1111/clr.13003. Epub 2017 Feb 13. — View Citation

Ucankale M, Akoglu B, Ozkan Y, Ozkan YK. The effect of different attachment systems with implant-retained overdentures on maximum bite force and EMG. Gerodontology. 2012 Mar;29(1):24-9. doi: 10.1111/j.1741-2358.2010.00389.x. Epub 2010 Jun 30. — View Citation

Uludag B, Polat S, Sahin V, Comut AA. Effects of implant angulations and attachment configurations on the retentive forces of locator attachment-retained overdentures. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1053-7. doi: 10.11607/jomi.3401. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in retention force The retention of a complete implant overdenture prosthesis is defined as the minimum retention force (N) required to separate the male part of the attachment from the female part. The retention strength will be measured 3 times with a force gauge that allows the application of the retention force perpendicular to the occlusal plane of the prosthesis and parallel to the long axis of the implant, and the values will be averaged with a digital dynamometer. As the measurement value increases, it is concluded that the retention of the prosthesis increases. The measurements will be recorded on the 'Patient Measurement Card' at each control session.
The retention of the implanted complete denture will be measured at the time of delivery of the implant overdenture to the patient and at the control sessions 1 week, 1 month, 3 months, and 6 months after the patient start to use the denture.
6 months
Secondary Change in patient satisfaction Patients' overall satisfaction, comfort, speech ability, prosthesis stability, retention, aesthetics, and ease of cleaning will be assessed using VAS measurements. The rating words will be 'very satisfied' and 'not at all satisfied,' and patients will be asked to draw a vertical line on a 10 cm horizontal line at the point that best represents their perception. The VAS total score is between 0-10. As the score increases, it is concluded that the patient's satisfaction increases. Patients will be asked to fill out the VAS questionnaire form during the 1st month (TI) after using the prosthesis and at 3 months and 6 months of control sessions. 6 months
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