Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT06819995
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06819995
Study Brief:
Protocol Section:
NCT06819995