NCT06571968

Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible

Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible by Using Fully Versus Semi Guided Prototyped Surgical Stent

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 58 Years – 68 Years
• Healthy volunteers: Accepted

Summary

Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.

Detailed description

Objectives: Current study aimed to assess the accuracy of fully- guided implant placement in completely lower edentulous patients compared to the semi-guided protocol. Materials and Methods: Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants. Measurements and analysis of results were performed by means of a software tool used during virtual planning (P3Dental; Protótipos).

Conditions

• Implant Placement

Interventions

Type	Name	Description
DEVICE	fully guided stent	All surgical procedures with drills were done through the stent., the implant was picked up from the implant holder and then installed, still with the surgical guide in situ, by using the ratchet and ratchet connector at a motor speed of 20 rpm, followed by cover screw placement without the need for sutures.
DEVICE	semiguided stent	The first osteotomy was performed with the surgical guide in situ using a 1.95 mm pilot-drill. Successive color coded implant drills were used to prepare implant osteotomies. When using each twist drill, a removable sleeve having a diameter to coincide with the drill and inserted into the sleeve of the surgical guide. The stereo lithographic guide template was removed and the receptor sites were irrigated with saline solution then the final drill of the implant system 3.5 mm diameter was used to finalize the osteotomy. The implant was gripped with the placement aid, released from the implant holder by 1/4 turn and manually inserted into the prepared implant site using a finger placement tool or hand ratchet. A torque of 45 N cm should not be exceeded during insertion procedure and cover screws were screwed over it.

Timeline

• Start date: 2023-05-14
• Primary completion: 2024-01-03
• Completion: 2024-02-02
• First posted: 2024-08-26
• Last updated: 2025-05-01

Locations

1 site across 1 country: Egypt