💬In plain words
What the trial is, and whether it could suit you
Dear Patient,
You are invited to participate in a clinical study. To understand the study, please carefully review the following information. If you have any questions, feel free to ask the dentist leading the study.
Dental implants are an effective, long-term solution for replacing missing teeth. They replace the root of a lost or unsalvageable tooth, supporting a crown or prosthesis to restore function and aesthetics. Proper placement is crucial for implants to function and last. Guided implant surgery is a technique that improves precision using customized surgical guides created from patient records, such as radiographs and scans. These guides act as templates to ensure accurate implant placement, optimizing functionality, aesthetics, and minimizing complications.
There are two main methods for fabricating surgical guides: milling, which cuts material into shape, and 3D printing,
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.