Two Versus Four Implant-supported Fixed Full-arch Prosthesis

NCT ID: NCT05290766

Last Updated: 2025-01-17

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2023-04-16

Brief Summary

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The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

Detailed Description

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* Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
* All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.

The patients will be divided into 2 groups

1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Conditions

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Prosthesis Durability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".

Group Type ACTIVE_COMPARATOR

placement of four dental implants

Intervention Type PROCEDURE

placement of four dental implants according to the " All on four concept"

mandibular full arch prosthesis

Intervention Type DEVICE

loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Study group

will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Group Type ACTIVE_COMPARATOR

placement of two dental implants

Intervention Type PROCEDURE

placement of two dental implants according to " All on two concepts"

mandibular full arch prosthesis

Intervention Type DEVICE

loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Interventions

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placement of four dental implants

placement of four dental implants according to the " All on four concept"

Intervention Type PROCEDURE

placement of two dental implants

placement of two dental implants according to " All on two concepts"

Intervention Type PROCEDURE

mandibular full arch prosthesis

loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I

Exclusion Criteria

* systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Mansoura University

Al Mansurah, Eldakahlia, Egypt

Site Status

Christine Ibrahim

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A03040122

Identifier Type: -

Identifier Source: org_study_id

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