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RCT X-GUIDE (50/2022)

Dynamic navigation vs. the freehand method
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06028750
Dynamic computer assisted implant surgery
Source : Importé depuis le centre
Recrutement fermé
Dernière modification : 2025/07/28
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Subjects who agree to voluntarily sign the informed consent before performing any action related to the study.
* Men or women at least 18 years old.
* Single edentulous spaces or edentulous sections located in maxilla or mandible with a healing period longer than 12 weeks to rehabilitate with implant-supported fixed crowns ≤3 units.
* O'Leary plaque and/or bleeding on probing index ≤25%.

Exclusion Criteria:

* Systemic diseases that may interfere with dental implant placement.
* Any contraindications for oral surgical procedures.
* History of head and neck radiotherapy.
* Patients smoking \>20 cigarettes/day or tobacco equivalents.
* History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the opinion of the investigator, could interfere with the patient's ability to cooperate and comply with the study.
* Patients who have participated in a clinical trial within the last 30 days.
* Pregnant or lactating women.
* Patients with poor or unmotivated oral hygiene.
* Probing depth with bleeding of ≥4 mm in one of the teeth adjacent to the edentulous space or tract.
* Need to perform guided bone regeneration procedures simultaneous to implant placement.
* Cases where the use of transepithelial abutments is not recommended (reduced prosthetic space, high esthetic demand associated with thin gingival biotypes, etc.).

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Freehand Nobel Replace Conical Connection® placed freehand Donnée non disponible
  • Inconnu
  • X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA) Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA) Donnée non disponible
  • Inconnu
  • Freehand
    État du recrutement
    unknown
    X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)
    État du recrutement
    unknown
    Données à jour depuis : 28 juillet 2025

    Description de l'étude

    Résumé de l'étude

    The purpose of the study is to evaluate in novice surgeons the accuracy of the X-Guide® navigation system (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.

    Source : Importé depuis le centre

    Randomized clinical trial with 2 parallel treatment groups. Eligible patients will be randomized with a 1:1 ratio to one of 2 possible parallel treatment groups:

    * Group 1: Nobel Replace Conical Connection® placed freehand.
    * Group 2: Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA).

    PRIMARY OBJECTIVE:

    - To evaluate in novice surgeons the accuracy of the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.

    SECONDARY OBJECTIVES:

    * To evaluate overall surgical time with the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) compared to freehand implant placement in inexperienced surgeons.
    * To evaluate Patient Reported Outcomes Measures (PROMs) during implant treatment with navigation systems performed by novice surgeons.

    Source : Importé depuis le centre

    Dernière modification : 28 juillet 2025
    Données à jour depuis : 31 juil.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06028750