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NCT05972538 Clinical Trial

Clinical Performance and Stability of Different Types of Implant Supported Overdenture

Complete Edentulism Clinical Trial

Official title:
Clinical Performance and Stability of Different Types of Implant Supported Overdenture

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05972538
Other study ID # 64312012023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date July 5, 2023

Study information
Verified date July 2023
Source National Research Centre, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Total number of 36 implants were installed in 6 patients having mandibular single denture. The patients were divided into two groups according to the definitive prosthesis. Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.

Description:

Implant's stability, clinical performance (gingival index, pocket depth, plaque index and bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days after prosthesis delivery

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date July 5, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - highly co-operative - non-smoker - systemically free from any chronic diseases Exclusion Criteria: - immunocompromised patients - patients having knife edge, flat or flabby ridge, - patients having T. M. J disorders

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Osstell ( Osstell AB, Goteborg, Sweden).
Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery
• periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
Other:
• questionnaire for patient satisfaction
A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

Locations
Country Name City State
Egypt National Research Centre Cairo Dokki

Sponsors (1)
Lead Sponsor Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of change in implant stability Assessment of implant stability by device ( Ostell device) on the 15th, 30th, 60th and 90th days of overdenture insertion
Primary Assessment of change in implants clinical performance throughout the follow-up period. Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe. on the 15th, 30th, 60th and 90th days of over denture insertion.
Secondary Assessment of patient satisfaction A questionnaire was used to evaluate patient satisfaction on the 90th day of prosthesis delivery
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