NCT05108324

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

October 11, 2021

Last Update Submit

November 3, 2021

Conditions

Edentulous; Alveolar Process, Atrophy

Keywords

all on fourzygomatic implant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Implant primary stability

    baseline Immediate after implantation

Other Outcomes (1)

  • Biologic complication and implant survival rate

    baseline and sixth months

Study Arms (2)

zygomatic implant

EXPERIMENTAL

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

Procedure: zygomatic implant

conventional implant

ACTIVE COMPARATOR

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

Procedure: conventional implant

Interventions

zygomatic implantPROCEDURE

2 zygomatic implants and 2 anterior conventional implant

Also known as: extramaxillary implant
zygomatic implant
conventional implantPROCEDURE

patients will receive 4 conventional dental implant

Also known as: all on 4
conventional implant

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mouth, EdentulousAtrophy

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Mohamed a. Atef, professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

MOSTAFA EL MASRY, doctor

CONTACT

+201221953838mostafa.elmasry@hotmail.com

Dalia ab radwan, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 11, 2021

First Posted

November 4, 2021

Study Start

November 10, 2021

Primary Completion

October 31, 2022

Study Completion

February 14, 2023

Last Updated

November 4, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

data to be shared after publication of the study

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after puplication
Access Criteria
data will be share upon request from Colleges