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

Not Applicable

• Conditions: Edentulous; Alveolar Process, Atrophy

• Registration Number: NCT05108324
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-11
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04
• Study Start: 2021-11-10
• Primary Completion: 2022-10-31
• Study Completion: 2023-02-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change of function of the masticatory muscles	baseline & 6 month after the delivery of the prothesis	measuring muscles activtiy of masseter and temporalis muscles by electromyography

Secondary Outcome Measures

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