Comparing dynamic navigation and freehand methods for dental implant placement
Accuracy of Dental Implant Placement Using Dynamic Navigation or the Freehand Method: a Randomized Controlled Clinical Trial in Novice Operators
This study is testing if using a special navigation system makes it easier and more accurate for new dentists to place dental implants compared to doing it by hand.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Barcelona Academic / other |
| Locations | 1 site (L´hospitalet de Llobregat, Catalunya) |
| Trial ID | NCT06028750 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the accuracy of the X-Guide® navigation system in placing dental implants by novice surgeons compared to traditional freehand methods. Participants will be randomly assigned to one of two groups: one using the X-Guide system and the other using freehand techniques. The study aims to assess not only the precision of implant placement but also the overall surgical time and patient-reported outcomes during the procedure. The trial focuses on single edentulous spaces in the maxilla or mandible that have healed for over 12 weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific edentulous spaces in the maxilla or mandible suitable for implant-supported crowns.
Not a fit: Patients with systemic diseases affecting dental procedures, those who smoke heavily, or individuals with a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of dental implant placements performed by novice surgeons, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results with navigation systems in dental implant placement, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.).
Where this trial is running
L´hospitalet de Llobregat, Catalunya
- University of Barcelona — L´hospitalet de Llobregat, Catalunya, Spain (Recruiting)
Study contacts
- Study coordinator: Octavi Camps Font, PhD
- Email: occafo@gmail.com
- Phone: 665-980-569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.