How accurate are metal sleeve–free fully guided dental implants?
Evaluation of Accuracy in Fully Guided Dental Implant Surgery Using 3D-Printed Surgical Guides Without Metal Sleeves: A Split-Mouth In Vivo Study
NA · Universidad Complutense de Madrid · NCT07364006
This trial will test if metal sleeve–free 3D-printed surgical guides, using two different drill channel sizes in a split-mouth design, place implants accurately in adults needing complete-arch dental rehabilitation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid (other) |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07364006 on ClinicalTrials.gov |
What this trial studies
This is a split-mouth interventional trial in partially or fully edentulous adults needing fixed complete-arch implants. Each participant will receive fully guided implant placement using 3D-printed surgical guides without metal sleeves, with standard and reduced drilling channel diameters randomly assigned to opposite sides. Postoperative intraoral scans and CBCTs with scan bodies will be used to register planned versus placed implant positions and measure linear and angular deviations. The primary analysis compares the deviations between the two channel diameters to determine whether removing metal sleeves and reducing channel diameter affects placement accuracy.
Who should consider this trial
Good fit: Adults (18+) who are partially or fully edentulous and require fixed complete-arch rehabilitation with dental implants, classified as ASA I or II, and able to give informed consent are ideal candidates.
Not a fit: Patients with ASA III–IV status, medical contraindications to implant surgery, inability to consent, or who do not require complete-arch rehabilitation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce implant placement deviations and improve prosthetic fit and clinical outcomes for complete-arch rehabilitations.
How similar studies have performed: Previous guided implant surgery research shows variable losses of accuracy compared with virtual planning, but in vivo evidence specifically on metal sleeve–free guides and reduced drill channel diameters is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Partially or fully edentulous patients requiring fixed complete-arch rehabilitation with dental implants. * Patients classified as ASA I or ASA II. * Adult patients aged 18 years or older. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * Patients classified as ASA III or ASA IV. * Patients with medical conditions that contraindicate dental implant surgery. * Inability or unwillingness to provide informed consent.
Where this trial is running
Madrid, Madrid
- Universidad Complutense de Madrid — Madrid, Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Juan Ballesteros, DDs, MSc — Universidad Complutense de Madrid Juan Ballesteros- Martinez, DDs, MSc
- Study coordinator: Miguel A Gómez Polo, DDS, PhD
- Email: mgomezpo@ucm.es
- Phone: +34659390001
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.
Conditions: Edentulism, Guided implant surgery, Dental implants, Surgical guide accuracy, Metal sleeve-free surgical guides, 3D-printed surgical guides