Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides

Launched by UNIVERSIDAD COMPLUTENSE DE MADRID · Feb 5, 2025

Keywords

ClinConnect Summary

**Summary of the Clinical Trial on Dental Implants**

This clinical trial is studying how accurately dental implants can be placed using two different methods of creating surgical guides: 3D printing and milling. Surgical guides are special templates that help dentists place implants precisely, which is important for the implants to work well and look good. The study will look at how well the implants function and how they integrate with the bone over time when using these two types of guides.

You may be eligible to participate in this study if you are 21 years or older and have one to four missing teeth that can be replaced with implants. Your overall dental health will be assessed to ensure you meet the criteria. If you join the study, you will undergo a thorough dental examination and then have the implant surgery, which will take about 1-2 hours. You will be randomly assigned to receive either a 3D-printed or a milled surgical guide, and you will have follow-up appointments to monitor your healing and the success of the implant over the next year. Participating in this study will save you costs for the implants and guides while providing you with close monitoring by dental professionals. Your participation is completely voluntary, and you can choose to withdraw at any time without affecting your dental care.

Gender

ALL

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.