Clinical Performance and Stability of Different Types of Implant Supported Overdenture

Not Applicable

Completed

• Conditions: Complete Edentulism
• Interventions: Device: Osstell ( Osstell AB, Goteborg, Sweden).; Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein; Other: questionnaire for patient satisfaction

• Registration Number: NCT05972538
• Lead Sponsor: National Research Centre, Egypt

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-05
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Osstell ( Osstell AB, Goteborg, Sweden).	patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.
Group I	questionnaire for patient satisfaction	patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.
Group II	questionnaire for patient satisfaction	patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.
Group I	periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein	patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.
Group II	Osstell ( Osstell AB, Goteborg, Sweden).	patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.
Group II	periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein	patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.

Primary Outcome Measures

Name	Time	Method
Assessment of change in implants clinical performance throughout the follow-up period.	on the 15th, 30th, 60th and 90th days of over denture insertion.	Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.
Assessment of change in implant stability	on the 15th, 30th, 60th and 90th days of overdenture insertion	Assessment of implant stability by device ( Ostell device)

Secondary Outcome Measures

Name	Time	Method
Assessment of patient satisfaction	on the 90th day of prosthesis delivery	A questionnaire was used to evaluate patient satisfaction

Trial Locations

Locations (1)

National Research Centre; 🇪🇬 Cairo, Dokki, Egypt