Dynamic Navigation vs. the Freehand Method

Last updated: June 5, 2024
Sponsor: University of Barcelona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Medical Prosthetics

Treatment

Dynamic Computer Assisted Surgery

Freehand

Clinical Study ID

NCT06028750
RCT X-GUIDE (50/2022)
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who agree to voluntarily sign the informed consent before performing anyaction related to the study.

  • Men or women at least 18 years old.

  • Single edentulous spaces or edentulous sections located in maxilla or mandible witha healing period longer than 12 weeks to rehabilitate with implant-supported fixedcrowns ≤3 units.

  • O'Leary plaque and/or bleeding on probing index ≤25%.

Exclusion

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., severepsychiatric illness) that, in the opinion of the investigator, could interfere withthe 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 edentulousspace or tract.

  • Need to perform guided bone regeneration procedures simultaneous to implantplacement.

  • Cases where the use of transepithelial abutments is not recommended (reducedprosthetic space, high esthetic demand associated with thin gingival biotypes,etc.).

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Dynamic Computer Assisted Surgery
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
November 30, 2024

Study Description

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.

Connect with a study center

  • University of Barcelona

    L´hospitalet de Llobregat, Catalunya 08903
    Spain

    Active - Recruiting

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