Dynamic Navigation vs. the Freehand Method (NCT06028750) | Clinical Trial Compass
CompletedNot Applicable
Dynamic Navigation vs. the Freehand Method
Spain60 participantsStarted 2023-09-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Through study completion, an average of 1 year.