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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Complete Edentulism

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