Status:
COMPLETED
Dynamic Navigation vs. the Freehand Method
Lead Sponsor:
University of Barcelona
Conditions:
Dental Implants
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 i...
Detailed 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 Conn...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06028750
Start Date
September 8 2023
End Date
November 1 2024
Last Update
July 29 2025
Active Locations (1)
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1
University of Barcelona
L'Hospitalet de Llobregat, Catalonia, Spain, 08903