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3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement

Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Guide Versus Modified Resin Guide

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07826039
Acronym
CGIIPMM-PLA-MR
Enrollment
20
Registered
2026-09-17
Start date
2025-11-02
Completion date
2026-09-10
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant Placement in Mandibular Molar Extraction Sockets

Keywords

Immediate implant placement, Computer-guided implant surgery, Mandibular molar, Modified resin surgical guide, 3D-printed PLA surgical guide

Brief summary

This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed PLA guide system and a modified resin guide system. The study evaluates implant positioning accuracy, primary implant stability, and surgical time.

Detailed description

This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed polylactic acid (PLA) guide system and a modified resin guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and fabrication of the surgical guides. Implant positioning accuracy was assessed by comparing the planned and actual implant positions using preoperative and postoperative CBCT datasets. Angular deviation, coronal deviation at the implant platform, and apical deviation were recorded. Primary implant stability was assessed immediately after implant placement using Implant Stability Quotient (ISQ) measurements obtained with an Osstell device. Surgical time was recorded from seating of the surgical guide and initiation of osteotomy until completion of implant insertion. The study was designed to compare the performance of the two guide systems in immediate mandibular molar implant placement.

Interventions

PROCEDUREimmediate implant placement using PLA guide

Preoperative virtual planning was performed using CBCT data and digital intraoral scans. The datasets were used for prosthetically driven implant planning and fabrication of a patient-specific 3D-printed PLA surgical guide. Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory. The implant was then immediately inserted. Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.

PROCEDUREImmediate implant placement using Modified resin guide.

Preoperative virtual planning was performed using CBCT data and digital intraoral scans. The datasets were used for prosthetically driven implant planning and fabrication of a tooth-supported modified resin surgical guide. Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory. The implant was then immediately inserted. Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.

Sponsors

Mohamed Esmail Ahmed Hassan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Age 20-50 years. * Non-restorable mandibular first molar indicated for extraction. * Sufficient bony support for implant placement without the need for significant bone augmentation. * Good oral hygiene and motivation. * Adequate prosthetic space. * Ability and willingness to undergo the surgical procedure and follow-up. * Suitable for computer-guided, tooth-supported implant placement.

Exclusion criteria

* Uncontrolled systemic diseases that may impair healing (e.g., uncontrolled diabetes or hypertension). * Severe periodontal disease. * Patients undergoing chemotherapy or radiotherapy. * Insufficient prosthetic space. * Heavy smokers.

Design outcomes

Primary

MeasureTime frameDescription
accuracy of implant positionAssessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.Accuracy of implant placement will be evaluated by comparing the planned implant position from the preoperative digital plan with the actual implant position obtained from the postoperative CBCT scan. Deviations will be assessed in three dimensions, including angular deviation (degrees), coronal deviation (platform) (mm), and apical deviation (mm). Measurements will be performed using specialized implant-planning software by superimposing the preoperative and postoperative datasets. Lower deviation values indicate greater agreement between the planned and actual implant positions.

Secondary

MeasureTime frameDescription
primary implant stability by osstellMeasured immediately at the time of implant placement during the surgical procedure.Primary implant stability will be assessed using an Osstell device, which measures Implant Stability Quotient (ISQ) values through resonance frequency analysis. A SmartPeg will be attached to the implant, and ISQ readings will be taken in two perpendicular directions (buccolingual and mesiodistal). Higher ISQ values indicate greater mechanical stability. The mean ISQ value for each implant will be recorded and used for analysis
surgical timeAssessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgerySurgical time will be recorded to evaluate the procedural efficiency of guided immediate implant placement. Time will be measured from seating of the surgical guide and initiation of osteotomy until completion of implant insertion. The total duration will be recorded in minutes.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026