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Guided Pterygoid Implant

NCT07016828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Atrophy of the Posterior Maxilla

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 will be either soft tissue without flap elevation.

PROCEDURE

Free hand technique

the surgery will be done without the use of the surgical guides depending on the anatomical landmarks.

Sponsors & Collaborators

  • Fayoum University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2026-06-01
Completion
2026-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016828 on ClinicalTrials.gov