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

Primary Purpose

Edentulous; Alveolar Process, Atrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
zygomatic implant
conventional implant
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Edentulous; Alveolar Process, Atrophy focused on measuring all on four, zygomatic implant

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    zygomatic implant

    conventional implant

    Arm Description

    patients receiving 2 zygomatic implants with 2 conventional implant in anterior region

    patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading

    Outcomes

    Primary Outcome Measures

    change of function of the masticatory muscles
    measuring muscles activtiy of masseter and temporalis muscles by electromyography

    Secondary Outcome Measures

    Implant primary stability
    The implant initial stability will be directly measured after implant insertion using the resonance frequency analysis technique by osttel device

    Full Information

    First Posted
    October 11, 2021
    Last Updated
    November 3, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05108324
    Brief Title
    Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 10, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Anticipated)
    Study Completion Date
    February 14, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous; Alveolar Process, Atrophy
    Keywords
    all on four, zygomatic implant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    zygomatic implant
    Arm Type
    Experimental
    Arm Description
    patients receiving 2 zygomatic implants with 2 conventional implant in anterior region
    Arm Title
    conventional implant
    Arm Type
    Active Comparator
    Arm Description
    patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading
    Intervention Type
    Procedure
    Intervention Name(s)
    zygomatic implant
    Other Intervention Name(s)
    extramaxillary implant
    Intervention Description
    2 zygomatic implants and 2 anterior conventional implant
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional implant
    Other Intervention Name(s)
    all on 4
    Intervention Description
    patients will receive 4 conventional dental implant
    Primary Outcome Measure Information:
    Title
    change of function of the masticatory muscles
    Description
    measuring muscles activtiy of masseter and temporalis muscles by electromyography
    Time Frame
    baseline & 6 month after the delivery of the prothesis
    Secondary Outcome Measure Information:
    Title
    Implant primary stability
    Description
    The implant initial stability will be directly measured after implant insertion using the resonance frequency analysis technique by osttel device
    Time Frame
    baseline Immediate after implantation
    Other Pre-specified Outcome Measures:
    Title
    Biologic complication and implant survival rate
    Description
    Any biological complication as sinusitis, fenestration, orbital insults, failure of the implant, are going to be assessed radiographically by the CBCT
    Time Frame
    baseline and sixth months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MOSTAFA EL MASRY, doctor
    Phone
    +201221953838
    Email
    mostafa.elmasry@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalia ab radwan, professor
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed a. Atef, professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

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

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