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Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla

NCT ID: NCT05108324

Last Updated: 2021-11-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2023-02-14

Brief Summary

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Oral rehabilitation by dental implants in the severely atrophic maxilla often represents a challenge. To overcome this difficulty, bone augmentation procedures such as sinus augmentation, guided bone regeneration (GBR), or distraction osteogenesis have been used to obtain adequate bone height and width for proper three-dimensional implant placement. To avoid surgical morbidity and shorten treatment length, alternative methods such as short or tilted implants, as well as zygomatic implants (ZIs),have been proposed and have shown promising outcomes.

Detailed Description

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Placement of dental implants in the pterygo-maxillary region provides adequate posterior bone support for the prosthesis which permits better distribution of masticatory forces without the need of sinus floor augmentation, onlay and inlay grafts, split crest technique, or osteogenic distraction. This allows rehabilitating patients with satisfactory full arch fixed maxillary prosthesis, which is usually spanned from second molar to contralateral second molar tooth.

The purpose of the present study is to compare the Reliability of all on four by 2 zygomatic implants with 2 conventional implant in anterior region versus all on four approach by conventional implant for the rehabilitation of the atrophied maxilla in terms of survival rates and improving the quality of patient's life and involved complication with maxillary sinus.

Conditions

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Edentulous; Alveolar Process, Atrophy

Keywords

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all on four zygomatic implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a randomized controlled trial - parallel group with the patients. It is a superiority trial.

study group are 10 patients receiving 2 zygomatic implants with 2 conventional implant in anterior region, while the control group are another 10 patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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zygomatic implant

patients receiving 2 zygomatic implants with 2 conventional implant in anterior region

Group Type EXPERIMENTAL

zygomatic implant

Intervention Type PROCEDURE

2 zygomatic implants and 2 anterior conventional implant

conventional implant

patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading

Group Type ACTIVE_COMPARATOR

conventional implant

Intervention Type PROCEDURE

patients will receive 4 conventional dental implant

Interventions

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zygomatic implant

2 zygomatic implants and 2 anterior conventional implant

Intervention Type PROCEDURE

conventional implant

patients will receive 4 conventional dental implant

Intervention Type PROCEDURE

Other Intervention Names

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extramaxillary implant all on 4

Eligibility Criteria

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Inclusion Criteria

1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored with other type of treatment.
2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of at least 2 conventional implants.

Exclusion Criteria

1. Patients with any systemic disease that might interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension and osteoporosis, etc.
2. Heavy smoker (\> 20 cigarettes daily) and patients with history para-functional habits (e.g. clenching or bruxism, etc.) were also excluded.
3. Intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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mostafa elmasry

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed a. Atef, professor

Role: STUDY_CHAIR

Cairo University

Central Contacts

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MOSTAFA EL MASRY, doctor

Role: CONTACT

Phone: +201221953838

Email: [email protected]

Dalia ab radwan, professor

Role: CONTACT

Other Identifiers

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10/11/2021

Identifier Type: -

Identifier Source: org_study_id