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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05675566
Enrollment
40
Registered
2023-01-09
Start date
2023-02-01
Completion date
2024-02-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaw

Keywords

Dental Prosthesis, Implant-Supported

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.

Interventions

None listed

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Change in retention force6 monthsThe 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

MeasureTime frameDescription
Change in patient satisfaction6 monthsPatients' 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026