Clinical Performance and Stability of Different Types of Implant Supported Overdenture

NCT ID: NCT05972538

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-07-05

Brief Summary

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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

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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

Conditions

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Complete Edentulism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
participants don't know which treatment type they received.

Study Groups

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Group I

patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.

Group Type ACTIVE_COMPARATOR

Osstell ( Osstell AB, Goteborg, Sweden).

Intervention Type DEVICE

Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery

periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein

Intervention Type DEVICE

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

questionnaire for patient satisfaction

Intervention Type OTHER

A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

Group II

patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.

Group Type EXPERIMENTAL

Osstell ( Osstell AB, Goteborg, Sweden).

Intervention Type DEVICE

Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery

periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein

Intervention Type DEVICE

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

questionnaire for patient satisfaction

Intervention Type OTHER

A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

Interventions

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Osstell ( Osstell AB, Goteborg, Sweden).

Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery

Intervention Type DEVICE

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

Intervention Type DEVICE

questionnaire for patient satisfaction

A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

Intervention Type OTHER

Other Intervention Names

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- Assessment of implants clinical performance

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nabil Elboraey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asmaa N. Elboraey, Asso, Prof

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, Dokki, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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64312012023

Identifier Type: -

Identifier Source: org_study_id

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