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COMPLETED
NCT07774052
NA

Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Graft Versus Conventional Immediate Implant Placement With Xenograft

Sponsor: Mahmoud Fawzy Mahmoud Mohamed

View on ClinicalTrials.gov

Summary

This randomized controlled clinical trial will evaluate a computer-guided immediate implant placement technique in non-restorable mandibular molars using a patient-specific 3D-printed polylactic acid (PLA) graft and implant position guide, compared with conventional immediate implant placement using xenograft for grafting of the jumping gap. Eligible patients requiring extraction and immediate implant placement in mandibular molars will be randomly allocated to either the PLA-guided intervention group or the conventional treatment group. In the intervention group, a patient-specific 3D-printed PLA graft and guide will be designed from preoperative CBCT data and used to guide implant placement in the digitally planned position. In the control group, immediate implant placement will be performed using the conventional protocol with xenograft grafting. The study will assess the primary stability of the dental implant and the accuracy of implant placement compared with the digitally planned position. Implant stability will be measured using the Osstell device, while implant position will be evaluated by superimposing the immediate postoperative CBCT scan on the preoperative CBCT using Blue-Sky Plan software. Patients will be followed clinically after surgery, with follow-up visits during the healing period and a six-month postoperative CBCT evaluation before implant loading.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2024-11-04

Completion Date

2026-05-31

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

DEVICE

Patient-Specific 3D-Printed PLA Socket Guide and Root-Form Scaffold

A patient-specific 3D-printed polylactic acid (PLA) socket-supported surgical guide was used to guide implant osteotomy preparation, combined with a customized root-form PLA scaffold designed to occupy the residual peri-implant socket gap and provide structural support during immediate implant placement in mandibular molars.

DEVICE

Conventional Immediate Implant Placement

Freehand immediate implant placement with particulate xenograft to fill the residual peri-implant socket gap.

Locations (1)

Department of Oral & Maxillofacial Surgery , Faculty of Oral & Dental Medicine , Future University in Egypt

New Cairo, Egypt