How accurate are metal sleeve–free fully guided dental implants?
Official title: Evaluation of Accuracy in Fully Guided Dental Implant Surgery Using 3D-Printed Surgical Guides Without Metal Sleeves: A Split-Mouth In Vivo Study
Run by Universidad Complutense de Madrid · NCT07364006 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT07364006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.