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

Completed

• Conditions: Edentulous Jaw

• Registration Number: NCT05675566
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-02-01
• Primary Completion: 2023-11-01
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Marmara University School of Dentistry; 🇹🇷 Istanbul, Turkey