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Clinical Trials/NCT05108324
NCT05108324
Unknown
Not Applicable

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)

Cairo University0 sites20 target enrollmentNovember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous; Alveolar Process, Atrophy
Sponsor
Cairo University
Enrollment
20
Primary Endpoint
change of function of the masticatory muscles
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2021
End Date
February 14, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mostafa elmasry

principle investigator

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

change of function of the masticatory muscles

Time Frame: baseline & 6 month after the delivery of the prothesis

measuring muscles activtiy of masseter and temporalis muscles by electromyography

Secondary Outcomes

  • Implant primary stability(baseline Immediate after implantation)

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