Clinical Trial

Guided Pterygoid Implant

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Record status
This record was last updated June 12, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
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. 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.
Trial Details
NCT Number NCT07016828
Lead Sponsor Fayoum University
Conditions Atrophy of the Posterior Maxilla
Enrollment 12 participants
Start Date 2025-07-30
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-12