Maxillary DeficiencyNCT06227351
Completely Versus Partially Guided Zygomatic Implant
A study testing completely limiting computer generated surgical three-dimensional guide and Partially limiting computer generated surgical three-dimensional guide in people with Maxillary Deficiency and Alveolar Bone Loss, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Deficiency, Alveolar Bone Loss
- What is being tested?
- completely limiting computer generated surgical three-dimensional guide and Partially limiting computer generated surgical three-dimensional guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2024to 25 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).
Who cannot join
- Patients with systemic conditions contra-indicating general anesthesia.
- Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- Patients with acute maxillary sinus infection or maxillary sinus cyst.
- Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Completely Versus Partially Limiting Computer Guided Zygomatic Implant Placement. a Randomized Controlled Study
The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
Read the detailed description
According to World Oral Health Organization (WHO), losing teeth and arch edentulism is the result of a life long history of oral diseases like advanced dental caries and severe periodontal disease. Complete tooth loss estimated global average prevalence is 7% among people aged 20 years and 23% among people aged 60 years or older. Tooth loss lead to bone resorption in all direction.
Non-grafting solutions have been developed to reduce risks, morbidity, and treatment time. These types of treatment are often preferred by patients, considering that they may minimize total treatment time and have less morbidity than staged procedures of grafting solutions.One of non-grafting solutions is the zygomatic implants.
Zygomatic implants have shown improved clinical results compared with bone grafting in compromised maxillary bone.But the same as any surgical procedure, placing zygomatic implants has potential complication, such as: oro-antral communication, paresthesia or altered sensation of the infra orbital nerve also penetration of the orbital cavity may occur. In order to achieve the optimal position of zygomatic implant, computer-based planning has been introduced with the use of surgical guides.
Surgical guides are classified according to design concepts for fabrication of surgical guide to non-limiting, partially limiting design and complete limiting. In partially limiting design,the first drill is used then the surgical guide is removed and the osteotomy and implant placement are completed in freehand while in complete limiting design all the instruments used in surgical procedure during implant placement are restricted.
In literature, there is low evidence of using partially guided surgery for zygomatic implant and also of comparing the two designs with each other. the aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
- Conditions
- Maxillary Deficiency, Alveolar Bone Loss
- Being tested
- completely limiting computer generated surgical three-dimensional guide, Partially limiting computer generated surgical three-dimensional guide
- Keywords
- zygomatic implant, guided surgery, deficient maxilla
- Medical subject headings
- Retrognathia, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completely limiting computer generated surgical three-dimensional guideProcedure or surgery
Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full thickness flap to expose the maxilla up to the fronto-zygomatic notch.
According to the zygoma anatomy-guided approach classification and previously planned surgery using Cone beam C.T lateral window and sinus foor lifting will be decided to be done or not.
After securing the surgical templates in its proper position, sequential osteotomy drilling will be performed in a steady in and out movement under copious sterile saline irrigation.The drills will be entering the maxilla palatally and puncturing the alveolar crest to reach the buccal side.The drills will be visualized through the bony window created until it reaches the zygomatic bone.Sequential drills with the uses of guided tubes,sleeves and keys will be used to guarantee that the implant have been placed in a fully completely guided manner.Afterwards the zygomatic implants will be placed.
Partially limiting computer generated surgical three-dimensional guideProcedure or surgery
Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full -thickness flap to expose the maxilla up to the fronto-zygomatic notch.
According to zygoma anatomy-guided approach classification and previously planned surgery using cone beam C.T.lateral window and sinus floor lifting will be decided to be done or not.After securing the surgical templates,The first drill only will be used using the guide then it will be removed and the other drills will be completed in a free hand without the use of guide to guarantee that the implant will be placed in partially guided manner.Afterwards the zygomatic implants will be placed.
| Study group | Role | What they receive |
|---|---|---|
| completely limiting computer generated surgical three-dimensional guide | Active comparator | patients in this group will receive zygomatic implant placed in a completely fully guided technique using surgical guide,keys and sleeves. Receives: Procedure: completely limiting computer generated surgical three-dimensional guide |
| Partially limiting computer generated surgical three-dimensional guide | Active comparator | patients in this group will receive zygomatic implant placed in a partially guided technique using surgical guide.The first drill only will be used with the guide then the guide will be removed and the whole procedure with the remaining drills will be completed in a free hand technique. Receives: Procedure: Partially limiting computer generated surgical three-dimensional guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant position
Comparing the position of implant post-operatively with the virtual planning pre-operatively.
Measured: one week after the surgery.
Secondary outcomes (1)
Surgery duration
By calculating the time from the start of surgery till the end of surgery.
Measured: from the start of surgery to the completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start5 Feb 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
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 Maxillary DeficiencyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized (1:1) clinical trial study formed of 2 competitive groups where 12 implants will be placed in 2 groups (6 for each group) to compare the accuracy of completely limiting computer generated surgical three-dimensional guide versus partially limiting computer generated surgical three-dimensional guide during placement of zygomatic implants in patients with atrophic maxillae.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Hassan Ghallab, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227351
- Sponsor's protocol ID
- Zygomatic Implant
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghallab MK, Shabaan AA, Al-Mahalawy H, Taha M. Accuracy of Zygomatic Implant Placement Using Completely Versus Partially Guided. BMC Oral Health. 2026 May 6;26(1):826. doi: 10.1186/s12903-026-08436-x.
PubMed 42087122
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Completely Versus Partially Limiting Computer Guided Zygomatic Implant Placement. a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06227351
- Acronym / sponsor ID
- Zygomatic Implant
- Conditions
- Maxillary Deficiency, Alveolar Bone Loss
- Keywords
- zygomatic implant, guided surgery, deficient maxilla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 26 Jan 2024 (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.
The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
Detailed description
According to World Oral Health Organization (WHO), losing teeth and arch edentulism is the result of a life long history of oral diseases like advanced dental caries and severe periodontal disease. Complete tooth loss estimated global average prevalence is 7% among people aged 20 years and 23% among people aged 60 years or older. Tooth loss lead to bone resorption in all direction.
Non-grafting solutions have been developed to reduce risks, morbidity, and treatment time. These types of treatment are often preferred by patients, considering that they may minimize total treatment time and have less morbidity than staged procedures of grafting solutions.One of non-grafting solutions is the zygomatic implants.
Zygomatic implants have shown improved clinical results compared with bone grafting in compromised maxillary bone.But the same as any surgical procedure, placing zygomatic implants has potential complication, such as: oro-antral communication, paresthesia or altered sensation of the infra orbital nerve also penetration of the orbital cavity may occur. In order to achieve the optimal position of zygomatic implant, computer-based planning has been introduced with the use of surgical guides.
Surgical guides are classified according to design concepts for fabrication of surgical guide to non-limiting, partially limiting design and complete limiting. In partially limiting design,the first drill is used then the surgical guide is removed and the osteotomy and implant placement are completed in freehand while in complete limiting design all the instruments used in surgical procedure during implant placement are restricted.
In literature, there is low evidence of using partially guided surgery for zygomatic implant and also of comparing the two designs with each other. the aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective randomized (1:1) clinical trial study formed of 2 competitive groups where 12 implants will be placed in 2 groups (6 for each group) to compare the accuracy of completely limiting computer generated surgical three-dimensional guide versus partially limiting computer generated surgical three-dimensional guide during placement of zygomatic implants in patients with atrophic maxillae.
| Arm | Type | Receives |
|---|---|---|
| completely limiting computer generated surgical three-dimensional guide | Active comparator | Procedure: completely limiting computer generated surgical three-dimensional guidepatients in this group will receive zygomatic implant placed in a completely fully guided technique using surgical guide,keys and sleeves. |
| Partially limiting computer generated surgical three-dimensional guide | Active comparator | Procedure: Partially limiting computer generated surgical three-dimensional guidepatients in this group will receive zygomatic implant placed in a partially guided technique using surgical guide.The first drill only will be used with the guide then the guide will be removed and the whole procedure with the remaining drills will be completed in a free hand technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 years.
- Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).
Key exclusion criteria (4 listed)
- Patients with systemic conditions contra-indicating general anesthesia.
- Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- Patients with acute maxillary sinus infection or maxillary sinus cyst.
- Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).
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 |
|---|---|---|
| completely limiting computer generated surgical three-dimensional guideLong mid-crestal incision from the right to the left maxillary tuberosity and raising a full thickness flap to expose the maxilla up to the fronto-zygomatic notch. According to the zygoma anatomy-guided approach classification and previously planned surgery using Cone beam C.T lateral window and sinus foor lifting will be decided to be done or not. After securing the surgical templates in its proper position, sequential osteotomy drilling will be performed in a steady in and out movement under copious sterile saline irrigation.The drills will be entering the maxilla palatally and puncturing the alveolar crest to reach the buccal side.The drills will be visualized through the bony window created until it reaches the zygomatic bone.Sequential drills with the uses of guided tubes,sleeves and keys will be used to guarantee that the implant have been placed in a fully completely guided manner.Afterwards the zygomatic implants will be placed. | Procedure or surgery | completely limiting computer generated surgical three-dimensional guide |
| Partially limiting computer generated surgical three-dimensional guideLong mid-crestal incision from the right to the left maxillary tuberosity and raising a full -thickness flap to expose the maxilla up to the fronto-zygomatic notch. According to zygoma anatomy-guided approach classification and previously planned surgery using cone beam C.T.lateral window and sinus floor lifting will be decided to be done or not.After securing the surgical templates,The first drill only will be used using the guide then it will be removed and the other drills will be completed in a free hand without the use of guide to guarantee that the implant will be placed in partially guided manner.Afterwards the zygomatic implants will be placed. | Procedure or surgery | Partially limiting computer generated surgical three-dimensional guide |
Primary outcome
Implant position
Time frame: one week after the surgery.
Comparing the position of implant post-operatively with the virtual planning pre-operatively.
1 secondary outcome
Surgery duration
Time frame: from the start of surgery to the completion of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 42087122Ghallab MK, Shabaan AA, Al-Mahalawy H, Taha M. Accuracy of Zygomatic Implant Placement Using Completely Versus Partially Guided. BMC Oral Health. 2026 May 6;26(1):826. doi: 10.1186/s12903-026-08436-x.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing completely limiting computer generated surgical three-dimensional guide and Partially limiting computer generated surgical three-dimensional guide in people with Maxillary Deficiency and Alveolar Bone Loss, run by Fayoum University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant position (time frame: one week after the surgery.). 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 NCT06227351, 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 27 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.