Skip to main content
OpenTrials
Completed

NCT Number: NCT05675566

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in retention force

    Time frame: 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 outcomes

  1. Change in patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Investigation of Time-Dependent Change of Retention Force of Mandibular Implant Overdenture and Evaluation of Patient Satisfaction: A Clinical Follow-up Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.