Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible

NCT06571968 | Completed DMC

• 1 other identifier: M05010322
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Placement

Keywords

Fully-guided surgical stent; semi-guided surgical stent; accuracy analysis

Outcome Measures

Primary Outcomes (1)

• Radio graphic evaluation (Angular deviation)

  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.

  one year

Secondary Outcomes (1)

• Radio graphic evaluation (linear deviation)

  one year

Study Arms (2)

fully guided surgical technique

OTHER

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.

Device: fully guided stent

semi guided surgical technique

OTHER

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

Device: semiguided stent

Interventions

fully guided stent DEVICE

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.

fully guided surgical technique

semiguided stent DEVICE

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.

semi guided surgical technique

Eligibility Criteria

• Age: 58 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient wearing maxillary conventional denture.
• All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
• They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
• All patients are of angel's class I maxillo-mandibular relationships.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa Aboelez

Al Mansurah, Egypt

Location

Related Publications (1)

• Malpartida-Carrillo V, Tinedo-Lopez PL, Ortiz-Culca F, Guerrero ME, Amaya-Pajares SP. Techniques for retrievability and for registering screw access holes in cement-retained implant-supported prostheses: A scoping review of the literature. J Prosthet Dent. 2020 Mar;123(3):427-433. doi: 10.1016/j.prosdent.2019.03.011. Epub 2019 Jul 12.

  PMID: 31307803 BACKGROUND

Study Officials

• marwa aboelez, Phd

  Mansoura University

  STUDY CHAIR

• Hassan Kheriba, Msd

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Dental professionals who were not informed about the group assignments carried out the assignment and randomization of patients to the treatment groups.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 26, 2024
• Study Start: May 14, 2023
• Primary Completion: January 3, 2024
• Study Completion: February 2, 2024
• Last Updated: May 1, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: when summary data are published
• Access Criteria: raw data , statistical tests

Locations

EG (1)