Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:21 PM
Study NCT ID:
NCT07016828
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Pterygoid Implant
Sponsor:
Fayoum University
Organization:
Study Overview
Official Title:
Comparing Accuracy of Pterygoid Implants Placement Using Computer-guided Surgical Templates Versus Free Hand Technique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: