Guided Pterygoid Implant
ConditionAtrophy of the Posterior Maxilla
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorFayoum University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients with systemic conditions contra-indicating general anesthesia.
Patients with acute maxillary sinus infection or maxillary sinus cyst.
Restricted mouth opening (less than 3cm inter-arch distance anteriorly).
Trial design
Treatments tested in this trial
- guided surgery technique
- Free hand technique
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov