An interventional study of guided surgery technique and Free hand technique in Atrophy of the Posterior Maxilla, sponsored by Fayoum University. Not yet recruiting at 1 site in Egypt. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Fayoum University · Not applicable, Interventional, and Treatment
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
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
Ethical Considerations Approved by institutional review boards, with informed consent and confidentiality maintained.
30 studies on the registry are indexed under Atrophic Maxilla; 11 are open to participants now.
This study's planned enrollment of 12 is below the median of 16 across 27 interventional studies indexed under Atrophic Maxilla.
Browse Atrophic Maxilla studies →Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Patients with conditions contraindicating implant placement (e.g.:
radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
Implants placed using CBCT-based 3D surgical guides.
Device: guided surgery technique
Freehand placement based on anatomical landmarks.
Procedure: Free hand 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.
the surgery will be done without the use of the surgical guides depending on the anatomical landmarks.
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: 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.
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.
Plan to share: Undecided — I still have no decision until i start my research and getting approvals from the patients to protect their right.
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Jun 2026, 10 months later.
Of 20 interventional studies with no phase under Atrophic Maxilla, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 32. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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