Atrophy of the Posterior MaxillaNCT07016828
Guided Pterygoid Implant
A study testing guided surgery technique and Free hand technique in people with Atrophy of the Posterior Maxilla, run by Fayoum University at 1 site in Egypt.
Trial summary
Introduction \& Background Alveolar ridge resorption after tooth extraction leads to significant bone loss, complicating prosthetic rehabilitation. Traditional bone grafting methods, though effective, involve long healing times and risks. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Atrophy of the Posterior Maxilla
- What is being tested?
- guided surgery technique and Free hand technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe posterior maxillary atrophy (Class V-VI Cawood \& Howell classification) requiring pterygoid implant placement.
- Patients with severe alveolar bone atrophy in posterior maxilla (Residual alveolar bone height <4mm in posterior maxilla precluding conventional implant placement).
- Adequate interarch space ≥7mm for prosthetic rehabilitation.
- Presence of pneumatized maxillary sinus with insufficient bone for sinus augmentation.
- Patients aged 21-75 years with completed craniofacial growth.
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 3cm inter-arch distance anteriorly).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Fayoum University
Al Fayyum, 63514
arfaa sabry hassan, professor, 0020842114095, ash02@fayoum.edu.eg
About this study
Official title: Comparing Accuracy of Pterygoid Implants Placement Using Computer-guided Surgical Templates Versus Free Hand Technique
Introduction \& Background Alveolar ridge resorption after tooth extraction leads to significant bone loss, complicating prosthetic rehabilitation. Traditional bone grafting methods, though effective, involve long healing times and risks. Pterygoid implants offer a graft-free alternative by engaging dense bone structures like the pterygoid process. However, their placement is technically challenging due to limited visibility and proximity to critical structures. Computer-guided surgery may improve accuracy and reduce complications compared to freehand techniques.
Research Question Does computer-guided surgery enhance the accuracy of pterygoid implant placement in atrophic maxillae compared to freehand techniques? Aim To compare the accuracy of computer-generated 3D surgical guides versus freehand placement of pterygoid implants.
Read more
Hypothesis
- H0: No difference in accuracy between techniques.
- Hₐ: there is difference between two techniques Study Design A prospective randomized controlled trial (1:1 allocation) with 12 implants (6 per group(.
Patient Selection Inclusion Criteria: Severe posterior maxillary atrophy (Cawood \& Howell V-VI), residual bone height <4mm, age 21-75.
Exclusion Criteria: Contraindications for surgery, uncontrolled systemic diseases, or acute sinus infections.
Methods
- Group A: Implants placed using CBCT-based 3D surgical guides.
- Group B: Freehand placement based on anatomical landmarks.
- Primary Outcome: Implant position accuracy (postoperative CBCT vs. virtual plan(.
- Secondary Outcomes: Surgical time, complications, and stability. Surgical Procedure
- Osteotomy: Angled drilling (45-60°) into the pterygoid process.
- Implant Placement: Torque ≥30 Ncm for primary stability.
- Postoperative Care: Antibiotics, analgesics, and follow-up CBCT at one week. Statistical Analysis Data analyzed using SPSS, with G*Power determining sample size (85% power, α = 0.05(.
Ethical Considerations Approved by institutional review boards, with informed consent and confidentiality maintained.
- Conditions
- Atrophy of the Posterior Maxilla
- Being tested
- guided surgery technique, Free hand technique
- Keywords
- guided surgery, pterygoid implant, atrophic maxilla
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided surgery techniqueDevice
- Clinical examination will be performed and preoperative CBCT will be taken for all the patients prior to the surgery to evaluate the posterior maxilla for the placement of the pterygoid implants.
- Ideal pterygoid implant placement will be planned using the BlueSky Bio software (USA) which will be mostly to emerge from the third molar position and to engage the dense pillar of bone formed by the pyramidal process and pterygoid process of sphenoid bone.
- surgical guide will be fabricated which will be either soft tissue without flap elevation.
Free hand techniqueProcedure or surgery
the surgery will be done without the use of the surgical guides depending on the anatomical landmarks.
| Study group | Role | What they receive |
|---|---|---|
| Guided Surgery group | Active comparator | Implants placed using CBCT-based 3D surgical guides. Receives: Device: guided surgery technique |
| free hand technique group | Placebo comparator | Freehand placement based on anatomical landmarks. Receives: Procedure: Free hand technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of implant position
The primary outcome will be measured by comparing the position of implant in the virtual plan with that in the postoperative implant or the actual implant and this will be done by making a superimposition of the virtual plan with the postoperative CBCT then putting points on the coronal and apical parts of implants and then start to measure the following data:
- direct linear measurements between the coronal and apical points of the virtual and actual implants (measured in millimeters)
- angular deviations between the long axis of virtual and postoperative or actual implants.(measured in degrees)
- indirect measurements of the coronal and apical points of virtual and actual implants to 3d planes.(measured in mm)
All of this will be done for both groups.
Measured: the patient will make postoperative CBCT after one week of the surgery to compare it with the preoperative virtual planning done on the preoperative CBCT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start30 Jul 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy of the Posterior MaxillaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Magdy Ahmed Yousef, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016828
- Sponsor's protocol ID
- pterygoid implant
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I still have no decision until i start my research and getting approvals from the patients to protect their right.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Accuracy of Pterygoid Implants Placement Using Computer-guided Surgical Templates Versus Free Hand Technique
- ClinicalTrials.gov ID
- NCT07016828
- Acronym / sponsor ID
- pterygoid implant
- Conditions
- Atrophy of the Posterior Maxilla
- Keywords
- guided surgery, pterygoid implant, atrophic maxilla
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Jun 2025 (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.
Introduction \& Background Alveolar ridge resorption after tooth extraction leads to significant bone loss, complicating prosthetic rehabilitation. Traditional bone grafting methods, though effective, involve long healing times and risks. Pterygoid implants offer a graft-free alternative by engaging dense bone structures like the pterygoid process. However, their placement is technically challenging due to limited visibility and proximity to critical structures. Computer-guided surgery may improve accuracy and reduce complications compared to freehand techniques.
Research Question Does computer-guided surgery enhance the accuracy of pterygoid implant placement in atrophic maxillae compared to freehand techniques? Aim To compare the accuracy of computer-generated 3D surgical guides versus freehand placement of pterygoid implants.
Hypothesis
- H0: No difference in accuracy between techniques.
- Hₐ: there is difference between two techniques Study Design A prospective randomized controlled trial (1:1 allocation) with 12 implants (6 per group(.
Patient Selection Inclusion Criteria: Severe posterior maxillary atrophy (Cawood \& Howell V-VI), residual bone height <4mm, age 21-75.
Exclusion Criteria: Contraindications for surgery, uncontrolled systemic diseases, or acute sinus infections.
Methods
- Group A: Implants placed using CBCT-based 3D surgical guides.
- Group B: Freehand placement based on anatomical landmarks.
- Primary Outcome: Implant position accuracy (postoperative CBCT vs. virtual plan(.
- Secondary Outcomes: Surgical time, complications, and stability. Surgical Procedure
- Osteotomy: Angled drilling (45-60°) into the pterygoid process.
- Implant Placement: Torque ≥30 Ncm for primary stability.
- Postoperative Care: Antibiotics, analgesics, and follow-up CBCT at one week. Statistical Analysis Data analyzed using SPSS, with G*Power determining sample size (85% power, α = 0.05(.
Ethical Considerations Approved by institutional review boards, with informed consent and confidentiality maintained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Surgery group | Active comparator | Device: guided surgery techniqueImplants placed using CBCT-based 3D surgical guides. |
| free hand technique group | Placebo comparator | Procedure: Free hand techniqueFreehand placement based on anatomical landmarks. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with severe posterior maxillary atrophy (Class V-VI Cawood \& Howell classification) requiring pterygoid implant placement.
- Patients with severe alveolar bone atrophy in posterior maxilla (Residual alveolar bone height <4mm in posterior maxilla precluding conventional implant placement).
- Adequate interarch space ≥7mm for prosthetic rehabilitation.
- Presence of pneumatized maxillary sinus with insufficient bone for sinus augmentation.
- Patients aged 21-75 years with completed craniofacial growth.
Key exclusion criteria (5 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 3cm 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 |
|---|---|---|
| guided surgery technique* Clinical examination will be performed and preoperative CBCT will be taken for all the patients prior to the surgery to evaluate the posterior maxilla for the placement of the pterygoid implants. * Ideal pterygoid implant placement will be planned using the BlueSky Bio software (USA) which will be mostly to emerge from the third molar position and to engage the dense pillar of bone formed by the pyramidal process and pterygoid process of sphenoid bone. * surgical guide will be fabricated which will be either soft tissue without flap elevation. | Device | Guided Surgery group |
| Free hand techniquethe surgery will be done without the use of the surgical guides depending on the anatomical landmarks. | Procedure or surgery | free hand technique group |
Primary outcome
Accuracy of implant position
Time frame: the patient will make postoperative CBCT after one week of the surgery to compare it with the preoperative virtual planning done on the preoperative CBCT.
The primary outcome will be measured by comparing the position of implant in the virtual plan with that in the postoperative implant or the actual implant and this will be done by making a superimposition of the virtual plan with the postoperative CBCT then putting points on the coronal and apical parts of implants and then start to measure the following data: 1. direct linear measurements between the coronal and apical points of the virtual and actual implants (measured in millimeters) 2. angular deviations between the long axis of virtual and postoperative or actual implants.(measured in degrees) 3. indirect measurements of the coronal and apical points of virtual and actual implants to 3d planes.(measured in mm) All of this will be done for both groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Undecided. I still have no decision until i start my research and getting approvals from the patients to protect their right.
Related trials for Atrophy of the Posterior Maxilla
Recruiting
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
RecruitingObservational study
Impact of Alveolar Ridge Preservation on the Potential Need for Sinus Floor Elevation: A 10-year Retrospective Radiographical Study
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Clinical and Patient Outcomes of 4 mm Ultra-Short vs. 8 mm Implants With Bone Augmentation in the Back Upper Jaw
Posterior Atrophic Maxilla
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided surgery technique and Free hand technique in people with Atrophy of the Posterior Maxilla, 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 5 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: opening soon, as of the sponsor's last update on 12 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact norhan magdy yousef, BDs (+201067534200, nm2650@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of implant position (time frame: the patient will make postoperative CBCT after one week of the surgery to compare it with the preoperative virtual planning done on the preoperative CBCT.). 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 12 Jun 2025.