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

Study Overview
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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.

Official Title
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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)

Conditions
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Edentulous; Alveolar Process, Atrophy

Intervention / Treatment
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* Procedure: zygomatic implant
* Procedure: conventional implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored with other type of treatment. 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: Patients with any systemic disease that might interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension and osteoporosis, etc. Heavy smoker (> 20 cigarettes daily) and patients with history para-functional habits (e.g. clenching or bruxism, etc.) were also excluded. Intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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all on four, zygomatic implant