Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT07016828
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.
Study:
NCT07016828
Study Brief:
Protocol Section:
NCT07016828