Guided Pterygoid Implant

Официальное название

Comparing Accuracy of Pterygoid Implants Placement Using Computer-guided Surgical Templates Versus Free Hand Technique

Обзор

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.

Вмешательства

• Устройство 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
• Процедура Free hand technique
  the surgery will be done without the use of the surgical guides depending on the anatomical landmarks.

Первичные конечные точки

• Accuracy of implant position [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Fayoum University — Al Fayyum

Идентификаторы

NCT: NCT07016828 · pterygoid implant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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