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Not yet recruiting NCT07016828

Guided Pterygoid Implant

No phase Interventional Atrophy of the Posterior Maxilla

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: guided surgery technique, Free hand technique.
Who it may be relevant to
Registry conditions: Atrophy of the Posterior Maxilla. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Fayoum University — Al Fayyum

Identifiers

NCT: NCT07016828 · pterygoid implant

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗