Comparing 3D-printed and milled surgical guides for dental implant placement

Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides, a Randomized Clinical Trial

This study tests whether 3D-printed or milled surgical guides work better for placing dental implants accurately to improve patient outcomes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Universidad Complutense de Madrid (other)
• Locations: 1 site (Madrid)
• Trial ID: NCT06819995 on ClinicalTrials.gov

What this trial studies

This study evaluates the accuracy of two methods for creating surgical guides used in dental implant placement: 3D printing and milling. Guided implant surgery utilizes customized guides based on patient-specific data to enhance the precision of implant placement, which is crucial for the success of the procedure. The study aims to determine which method provides better accuracy in positioning dental implants, thereby potentially improving patient outcomes. Participants will undergo implant placement using either a 3D-printed guide or a milled guide, and the results will be compared to assess effectiveness.

Who should consider this trial

Good fit: Ideal candidates include patients with one to four missing teeth who are planning to receive dental implants and have sufficient bone structure for implant placement.

Not a fit: Patients with significant periodontal disease or those who do not meet the bone structure requirements for implant placement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved accuracy in dental implant placements, resulting in better functional and aesthetic outcomes for patients.

How similar studies have performed: Previous studies have shown promising results in the accuracy of guided implant surgery, but this specific comparison of 3D printing versus milling is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Male or female patients with one to four missing teeth, where dental implants are planned and where a tooth-supported or tooth-mucosal supported surgical guides can be fabricated. Free-ended situations will be allowed.
* Edentulous sites with at least 3 months of healing after tooth extraction.
* Staged hard and soft tissue augmentation will be permitted. In cases of previous bone augmentation (e.g. staged horizontal bone regeneration or lateral sinus lift), a minimum healing period of 6 months should be respected. In cases of previous soft tissue augmentation procedures, a minimum healing period of 2 months should be respected. Simultaneous close sinus lift procedures will be allowed when there is a minimum posterior bone height of 6 mm.
* Implants should be surrounded by at least 1.5 mm of bone.
* Periodontally healthy patients or with stable periodontal conditions after periodontal therapy. Periodontitis will be defined according to the EFP-AAP 2017 World Workshop Classification (Papapanou PN, Sanz M, et al., 2018): interdental CAL is detectable at ≥2 non-adjacent teeth or buccal or oral CAL ≥3 mm with pocketing ≥3 mm is detectable at ≥2 teeth, but the observed CAL cannot be ascribed to non-periodontitis-related causes such as 1) gingival recession of traumatic origin; 2) dental caries extending in the cervical area of the tooth; 3) the presence of CAL on the distal aspect of a second molar and associated with malposition or extraction of a third molar, 4) an endodontic lesion draining through the marginal periodontium; and 5) the occurrence of a vertical root fracture.
* Aged 21 years and over and able to sign an informed consent form.
* Enough available bone assessed on CBCT to place Klockner Vega implants of diameters ranging from 3.5 to 4.5 mm and lengths between 8 and 12 mm.

Exclusion Criteria:

1. Systemic

   * Completely edentulous patients or patients requiring mucosal- or bone-supported surgical guides.
   * Compromised general health (ASA IV-VI patients).
   * Systemic diseases which could influence the outcome of therapy (uncontrolled diabetes mellitus, bone disorders, etc.).
   * Pregnant or nursing women.
   * Chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAID), or immune-modulator drugs (any type and dose).
   * Patients who need medications that affect bone metabolism (bisphosphonates, any type and dose).
   * Chronic diseases of the oral mucosa.
   * Smokers of \>10 cigarettes/day.
   * \>25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and OHI
   * Unable to attend all study visits.
   * Need of simultaneous bone augmentation after implant placement to treat dehiscence and fenestration type defects or to augment bone contour (\<1.5 mm of bone all around the implant circumference).
2. During surgery

   * Lack of primary stability assessed by hand testing after implant placement.
   * Less of 2 mm of keratinized mucosa, both at the lingual and buccal sites.
   * Lack of guide adjustment verified through the fitting windows.

Where this trial is running

Madrid

• Facultad de Odontología, Universidad Complutense de Madrid — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Mariano Sanz, DDS, PHD, DrHC — Facultad de Odontología, Departamento de Especialidades Clínicas Odontológicas, Universidad Complutense de Madrid
• Study coordinator: Ignacio Sanz-Sánchez, DDS, MSc, PHD

Conditions: Dental Implant, Guided Surgery Accuracy, Dental implant, Guided surgery, Surgical guide, 3D printing, Milling