Edentulous Maxilla, AtrophicG-PTERYGOIDNCT07840339
Guided Pterygoid Implants: an Accuracy Study
A study testing 3D Printed Digital Surgical Guide in people with Edentulous Maxilla, Atrophic, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this clinical study is to evaluate the accuracy of placing pterygoid implants using custom-made surgical guides in patients with atrophied posterior maxilla. The study focuses on measuring how closely the actual implant position matches the virtual preoperative plan in terms of angle and distance. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Edentulous Maxilla, Atrophic
- What is being tested?
- 3D Printed Digital Surgical Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Aug 2024to 10 Apr 2026
- 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
- No healthy volunteers
- Adult
Who may be able to join
- The age of the patients is between 20 and 60 years.
- Partially and completely maxillary edentulous patients whose sinus pneumatization and refuse other treatment options.
- Bone height related to the sinus is less than 5 mm.
Who cannot join
- Soft and hard tissue pathology at the operation site
- Patients with uncontrolled systemic disease
- Prior radiation therapy
- Previous chemotherapy and/or antiresorptive agents
- Heavy smoking (e.g., two packs per day)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
(Faculty of Dentistry - Tanta University
Tanta, Gharbia Governorate, 35111
About this study
Official title: Evaluation of the Accuracy of Pterygoid Implant Placement Using a Custom-Made Surgical Guide for the Rehabilitation of Atrophic Posterior Maxilla
The aim of this clinical study is to evaluate the accuracy of placing pterygoid implants using custom-made surgical guides in patients with atrophied posterior maxilla. The study focuses on measuring how closely the actual implant position matches the virtual preoperative plan in terms of angle and distance.
Read the detailed description
Rehabilitation of the atrophic posterior maxilla remains a surgical challenge. This study utilizes pterygoid implants as a graftless solution. For each participant, a digital workflow is followed: a cone-beam computed tomography (CBCT) scan and an intraoral scan are performed to design a custom-made surgical guide. Following implant placement, a postoperative CBCT is obtained. The accuracy is then evaluated by superimposing the planned and actual implant positions to calculate the coronal, apical, and angular deviations.
- Conditions
- Edentulous Maxilla, Atrophic
- Being tested
- 3D Printed Digital Surgical Guide
- Keywords
- Bone support vs mucosa support, Pterygoid implant, Accuracy of the surgical guide, Computer-Aided Design
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Digital Surgical GuideDevice
A custom-made surgical template designed using technology based on the patient's CBCT and intraoral scans. It is used to guide the surgical drills and the placement of pterygoid implants according to a pre-planned virtual position to ensure accuracy
| Study group | Role | What they receive |
|---|---|---|
| Guided Pterygoid Implant | Experimental | Patients with atrophic posterior maxilla receiving pterygoid implants using a custom-made digital surgical guide to evaluate placement accuracy. Receives: Device: 3D Printed Digital Surgical Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of custom-made surgical guide
Evaluation of the deviation between the virtual preoperative plan and the actual postoperative implant position. This includes angular (measured in angle degrees) and linear deviation (measured in mm).
Measured: Immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start22 Aug 2024
- Primary completion8 Aug 2025
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Maxilla, AtrophicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Taha Abushahba, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840339
- Sponsor's protocol ID
- OS 6-24/2219
- Acronym
- G-PTERYGOID
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Pterygoid Implant Placement Using a Custom-Made Surgical Guide for the Rehabilitation of Atrophic Posterior Maxilla
- ClinicalTrials.gov ID
- NCT07840339
- Acronym / sponsor ID
- G-PTERYGOID / OS 6-24/2219
- Conditions
- Edentulous Maxilla, Atrophic
- Keywords
- Bone support vs mucosa support, Pterygoid implant, Accuracy of the surgical guide, Computer-Aided Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 25 Sep 2026 (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 this clinical study is to evaluate the accuracy of placing pterygoid implants using custom-made surgical guides in patients with atrophied posterior maxilla. The study focuses on measuring how closely the actual implant position matches the virtual preoperative plan in terms of angle and distance.
Detailed description
Rehabilitation of the atrophic posterior maxilla remains a surgical challenge. This study utilizes pterygoid implants as a graftless solution. For each participant, a digital workflow is followed: a cone-beam computed tomography (CBCT) scan and an intraoral scan are performed to design a custom-made surgical guide. Following implant placement, a postoperative CBCT is obtained. The accuracy is then evaluated by superimposing the planned and actual implant positions to calculate the coronal, apical, and angular deviations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Pterygoid Implant | Experimental | Device: 3D Printed Digital Surgical GuidePatients with atrophic posterior maxilla receiving pterygoid implants using a custom-made digital surgical guide to evaluate placement accuracy. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The age of the patients is between 20 and 60 years.
- Partially and completely maxillary edentulous patients whose sinus pneumatization and refuse other treatment options.
- Bone height related to the sinus is less than 5 mm.
Key exclusion criteria (5 listed)
- Soft and hard tissue pathology at the operation site
- Patients with uncontrolled systemic disease
- Prior radiation therapy
- Previous chemotherapy and/or antiresorptive agents
- Heavy smoking (e.g., two packs per day)
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 |
|---|---|---|
| 3D Printed Digital Surgical GuideA custom-made surgical template designed using technology based on the patient's CBCT and intraoral scans. It is used to guide the surgical drills and the placement of pterygoid implants according to a pre-planned virtual position to ensure accuracy | Device | Guided Pterygoid Implant |
Primary outcome
Accuracy of custom-made surgical guide
Time frame: Immediately postoperative
Evaluation of the deviation between the virtual preoperative plan and the actual postoperative implant position. This includes angular (measured in angle degrees) and linear deviation (measured in mm).
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 3D Printed Digital Surgical Guide in people with Edentulous Maxilla, Atrophic, run by Tanta 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 3 inclusion and 5 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 29 Sep 2026. 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?
Accuracy of custom-made surgical guide (time frame: Immediately postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.