NOT YET RECRUITING
NCT07016828
Guided Pterygoid Implant
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.
Gender: All
Ages: 21 Years - 75 Years
Atrophy of the Posterior Maxilla