Time-dependent Change in the Retention Force of the Implant Overdenture

Sponsor
Marmara University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05675566
Collaborator
(none)
40
1
12
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Investigation of Time-Dependent Change of Retention Force of Mandibular Implant Overdenture and Evaluation of Patient Satisfaction: A Clinical Follow-up Study
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change in retention force [6 months]

      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.

    Secondary Outcome Measures

    1. Change in patient satisfaction [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marmara University School of Dentistry Istanbul Turkey 34854

    Sponsors and Collaborators

    • Marmara University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ferit Bayram, Assist. Prof., Marmara University
    ClinicalTrials.gov Identifier:
    NCT05675566
    Other Study ID Numbers:
    • MUDHF_PTT_01
    First Posted:
    Jan 9, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ferit Bayram, Assist. Prof., Marmara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2023