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Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible

NCT06571968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • marwa aboelez, Phd · Mansoura University

  • Hassan Kheriba, Msd · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
58 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-14
Primary Completion
2024-01-03
Completion
2024-02-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571968 on ClinicalTrials.gov