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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05108324
Collaborator
(none)
20
2
15.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: zygomatic implant
  • Procedure: conventional implant
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
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)
Anticipated Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Feb 14, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Other Outcome Measures

    1. Biologic complication and implant survival rate [baseline and sixth months]

      Any biological complication as sinusitis, fenestration, orbital insults, failure of the implant, are going to be assessed radiographically by the CBCT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mostafa elmasry, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05108324
    Other Study ID Numbers:
    • 10/11/2021
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by mostafa elmasry, principle investigator, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 4, 2021