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

Reliability of All on Four Using 2 Zygomatic and 2 Conventional Implants Versus Conventional All on Four Implants Simultaneously for the Rehabilitation of the Atrophied Maxilla (A Randomized Control Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Edentulous; Alveolar Process, Atrophy
• Intervention / Treatment: Procedure: zygomatic implant; Procedure: conventional implant

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MOSTAFA EL MASRY, doctor; Phone Number: +201221953838; Email: mostafa.elmasry@hotmail.com
• Study Contact Backup: Name: Dalia ab radwan, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zygomatic implant; patients receiving 2 zygomatic implants with 2 conventional implant in anterior region	Procedure: zygomatic implant; 2 zygomatic implants and 2 anterior conventional implant; Other Names: extramaxillary implant
Active Comparator: conventional implant; patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading	Procedure: conventional implant; patients will receive 4 conventional dental implant; Other Names: all on 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of function of the masticatory muscles	measuring muscles activtiy of masseter and temporalis muscles by electromyography	baseline & 6 month after the delivery of the prothesis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant primary stability	The implant initial stability will be directly measured after implant insertion using the resonance frequency analysis technique by osttel device	baseline Immediate after implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biologic complication and implant survival rate	Any biological complication as sinusitis, fenestration, orbital insults, failure of the implant, are going to be assessed radiographically by the CBCT	baseline and sixth months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed a. Atef, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): February 14, 2023

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: all on four; zygomatic implant
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 10/11/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: data to be shared after publication of the study
• IPD Sharing Time Frame: after puplication
• IPD Sharing Access Criteria: data will be share upon request from Colleges
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No