NCT05675566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

December 22, 2022

Last Update Submit

March 11, 2024

Conditions

Keywords

Dental Prosthesis, Implant-Supported

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in patient satisfaction

    6 months

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Our study will include individuals who have been rehabilitated with implant overdentures at Marmara University Faculty of Dentistry, Department of Prosthodontics.

You may qualify if:

  • years old,
  • Volunteer to participate in the study,
  • Upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related 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.

    PMID: 21365055BACKGROUND
  • 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.

    PMID: 22004061BACKGROUND
  • 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.

    PMID: 19500236BACKGROUND
  • 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.

    PMID: 19912482BACKGROUND
  • 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.

    PMID: 28191678BACKGROUND
  • 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.

    PMID: 20604812BACKGROUND
  • 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.

    PMID: 25216129BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

February 1, 2023

Primary Completion

November 1, 2023

Study Completion

February 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations