Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible

Not Applicable

Completed

• Conditions: Implant Placement
• Interventions: Device: fully guided stent

• Registration Number: NCT06571968
• Lead Sponsor: Mansoura University

Brief 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).

Study Timeline

• Study Start: 2023-05-14
• Primary Completion: 2024-01-03
• Study Completion: 2024-02-02
• Status Verified: 2024-07
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
• Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
• Long term immunosuppress and corticosteroid drug therapy.
• Patient with abnormal habits as clenching and bruxism.
• Smoking patient.
• Patient with problems in TMJ

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fully guided surgical technique	fully guided stent	The guides were designed with metal sleeves for guided drilling and guided implant placement and additional guide sleeves for the stabilization of the template by fixation screws.The implant width and length were selected for each patient according to previous 3d cone beam, and the drills of this kit were 11 mm longer than conventional drills. The surgery was performed without flap elevation. The guide was seated and fixed by means of 2-mm cortical screws in the buccal region after using of the corresponding drills.
semi guided surgical technique	fully guided stent	The guides were designed with metal sleeves for guided drilling and guided implant placement and additional guide sleeves for the stabilization of the template by fixation screws.The implant width and length were selected for each patient according to previous 3d cone beam, and the drills of this kit were 11 mm longer than conventional drills.The surgery was performed without flap elevation. The stent was removed before the final drilling

Primary Outcome Measures

Name	Time	Method
Radio graphic evaluation (Angular deviation)	one year	For both groups, postoperative CBCT scan was performed after implant placement. The same parameters of preoperative CBCT were followed according to the patient's position, image acquisition, and use of the same apparatus. This scan was performed with the same dental prosthesis as that used for the initial preoperative CBCT scanning, equipped with the gutta percha references, for superimposition of the images. The previously fabricated occlusal registration was used to align the prosthesis. Both CBCT scans were superimposed, and the software compared preoperative horizontal (Mesiodistal and buccolingual), vertical and angular virtual measurements of planned implants with real measurements of the placed implants.

Secondary Outcome Measures

Name	Time	Method
Radio graphic evaluation (linear deviation)	one year	For both groups, postoperative CBCT scan was performed after implant placement. The same parameters of preoperative CBCT were followed according to the patient's position, image acquisition, and use of the same apparatus. This scan was performed with the same dental prosthesis as that used for the initial preoperative CBCT scanning, equipped with the gutta percha references, for superimposition of the images. The previously fabricated occlusal registration was used to align the prosthesis. Both CBCT scans were superimposed, and the software compared preoperative horizontal (Mesiodistal and buccolingual) measurements of planned implants with real measurements of the placed implants.

Trial Locations

Locations (1)

Marwa Aboelez; 🇪🇬 Mansoura, Egypt