NCT06794138

The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery.

The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery, a Retrospective Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the success of implant-borne prostheses and the accuracy of implant placement that can be achieved using fully guided static Computer Assisted Implant Surgery (sCAIS). Additional aims included the evaluation of the stability and health of hard and soft tissues, respectively surrounding the dental implants.

Detailed description

Surgical planning A virtual planning software is used for surgical planning. Cone beam computed tomography (CBCT) reconstruction and intraoral scans are registered. Prosthetic plans are created in the software, or the radiological template was used as one. The angulation and position of the dental implants are determined by the prosthetic plan. Surgical guides The surgical templates are manufactured by rapid prototyping (3D printing). To guide the drills for implant bed preparation sleeves are inserted in the surgical guides. Surgical protocol Surgical interventions are performed by a single clinician experienced in dental implant placement and static navigation. Patients rinse with 0.2% chlorhexidine solution for 1 min before surgery. The fit of the surgical guide is checked under local anesthesia. Fully guided implant bed preparation is performed. Dental implants are placed non-submerged. Sutures are removed at 7 days postop. The prosthetic stages of treatment begin after a two-month healing period. Prosthetic procedures Implant-borne overdentures are manufactured using a hybrid (analog-digital) workflow. An open tray impression is taken using a medium body silicone impression material to capture the position of the implant platforms. An overdenture and a bar mesostructure are manufactured by the dental laboratory with a precision attachment. Fixed partial dentures (FPD) are manufactured using either a hybrid or a digital workflow. An open tray impression is taken using a medium body silicone impression material or postoperative intraoral scans are performed with scan bodies to capture the position of the implant platforms. Screw or cement-retained porcelain fused to metal FDPs are manufactured by the dental laboratory. Pre-contacts are finished using articulating papers until balanced occlusion in cases of overdentures or lateral guidance in cases of FPDs are obtained. Patients are recalled twice per year for controls and professional dental hygiene intervention.

Conditions

• Edentulism

Interventions

Type	Name	Description
PROCEDURE	dental implant placement	The fit of the surgical guide was checked and a flapless procedure was performed under local anesthesia. However, in cases where the width of keratinized mucosa was insufficient a limited full-thickness flap was elevated. The surgical template was fixed on the remaining dentition and mucosa using template fixation pins. Fully guided implant bed preparation was performed. Osteotomies were carried out with external cooling at a drill rotation speed of 800 rpm. Implant placement was performed using a manual torque wrench Dental implants were placed non-submerged. In cases of flap elevation, wound margins were stabilized with single interrupted sutures. Sutures were removed at 7 days postop.

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-01-27
• Last updated: 2025-08-01

Locations

1 site across 1 country: Hungary