Edentulous; Alveolar Process, AtrophyNCT05108324
Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla
A study testing zygomatic implant and conventional implant in people with Edentulous; Alveolar Process, Atrophy, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous; Alveolar Process, Atrophy
- What is being tested?
- zygomatic implant and conventional implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2021to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Dalia ab radwan, professor contact
About this study
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)
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.
Read the 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.
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Being tested
- zygomatic implant, conventional implant
- Keywords
- all on four, zygomatic implant
- Medical subject headings
- Mouth, Edentulous, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zygomatic implantProcedure or surgery
Also called extramaxillary implant
2 zygomatic implants and 2 anterior conventional implant
conventional implantProcedure or surgery
Also called all on 4
patients will receive 4 conventional dental implant
| Study group | Role | What they receive |
|---|---|---|
| zygomatic implant | Experimental | patients receiving 2 zygomatic implants with 2 conventional implant in anterior region Receives: Procedure: zygomatic implant |
| conventional implant | Active comparator | patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading Receives: Procedure: conventional implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of function of the masticatory muscles
measuring muscles activtiy of masseter and temporalis muscles by electromyography
Measured: baseline & 6 month after the delivery of the prothesis
Secondary outcomes (1)
Implant primary stability
The implant initial stability will be directly measured after implant insertion using the resonance frequency analysis technique by osttel device
Measured: baseline Immediate after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 Nov 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion14 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous; Alveolar Process, AtrophyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa elmasry, Cairo University
- Investigators
- Mohamed a. Atef, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108324
- Sponsor's protocol ID
- 10/11/2021
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data to be shared after publication of the study
Publications
Masry ME, Shawky M, Elhabashy H, Kadry W, Moutamed G, Atef M. Comparative Evaluation of All-on-Four Rehabilitation Using Zygomatic and Conventional Implants in Patients With Atrophied Maxilla. J Craniofac Surg. 2026 Jun 29. doi: 10.1097/SCS.0000000000013114. Online ahead of print.
PubMed 42371728
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05108324
- Acronym / sponsor ID
- 10/11/2021
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Keywords
- all on four, zygomatic implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 14 Feb 2023 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| zygomatic implant | Experimental | Procedure: zygomatic implantpatients receiving 2 zygomatic implants with 2 conventional implant in anterior region |
| conventional implant | Active comparator | Procedure: conventional implantpatients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zygomatic implantAlso: extramaxillary implant2 zygomatic implants and 2 anterior conventional implant | Procedure or surgery | zygomatic implant |
| conventional implantAlso: all on 4patients will receive 4 conventional dental implant | Procedure or surgery | conventional implant |
Primary outcome
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
1 secondary outcome
Implant primary stability
Time frame: baseline Immediate after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Derived from this study: PubMed 42371728Masry ME, Shawky M, Elhabashy H, Kadry W, Moutamed G, Atef M. Comparative Evaluation of All-on-Four Rehabilitation Using Zygomatic and Conventional Implants in Patients With Atrophied Maxilla. J Craniofac Surg. 2026 Jun 29. doi: 10.1097/SCS.0000000000013114. Online ahead of print.
- Individual participant dataSharing planned: Yes. data to be shared after publication of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia ab radwan, professor contact
Mohamed a. Atef, professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing zygomatic implant and conventional implant in people with Edentulous; Alveolar Process, Atrophy, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOSTAFA EL MASRY, doctor (+201221953838, mostafa.elmasry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of function of the masticatory muscles (time frame: baseline & 6 month after the delivery of the prothesis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.