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3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement (CGIIPMM-PLA-MR)

12 settembre 2026 aggiornato da: Mohamed Esmail Ahmed Hassan

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
    • New Cairo
      • Cairo, New Cairo, Egitto, 11511
        • Future University in Egypt (FUE)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: patient specific 3d printed PLA guide
Immediate implant placement in mandibular molar extraction sockets using a patient-specific tooth-supported 3D-printed PLA surgical guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication. The guide was fabricated from PLA according to the planned implant position. Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion. Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
Procedura: immediate 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.
Comparatore attivo: Modified Resin guide
Immediate implant placement in mandibular molar extraction sockets using a tooth-supported modified resin surgical guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication. The guide was fabricated from light-cured surgical-guide resin according to the planned implant position. Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion. Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
Procedura: Immediate 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
accuracy of implant position
Lasso di tempo: Assessed 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.
Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
primary implant stability by osstell
Lasso di tempo: Measured 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
Measured immediately at the time of implant placement during the surgical procedure.
surgical time
Lasso di tempo: Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
Surgical 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.
Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mohamed Esmail Ahmed Hassan

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 novembre 2025

Completamento primario (Effettivo)

10 agosto 2026

Completamento dello studio (Effettivo)

10 settembre 2026

Date di iscrizione allo studio

Primo inviato

12 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2026

Primo Inserito (Effettivo)

17 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • FUE.REC(78)/10-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because of participant privacy and confidentiality considerations. Only aggregate study results will be reported.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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