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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05676268
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥18 years
* Written informed consent
* Patients with systemic health or controlled medical conditions
* Patients with healthy or treated periodontal conditions
* Patients enrolled in regular supportive periodontal therapy (SPT)
* Patients without clinical signs of bruxism and/or oral parafunctions
* 2 osseointegrated dental implants in the canine or posterior areas of maxilla and mandible following transmucosal placement and healing of 3-6 months
* Tissue level solid-screw implants with a sand-blasted and acid- etched (SLA) surface with an endosseous diameter of 3.3, 4.1 or 4.8 mm, a length of 8, 10 or 12 mm, a shoulder diameter of 4.8 mm and a supracrestal machined neck with a height of 1.8 or 2.8 mm (Straumann® Dental Implant System, Institut Straumann AG, Basel, Switzerland)
* Full-ceramic
* Utilization of prefabricated titanium abutments
* Cemented (3M™ ESPE Ketac™ Cem, Seefeld, Germany) or screw-retained fixed dental prostheses with a mesial or distal cantilever extension (FDPCs)
* Cantilever extension corresponding to 1 premolar unit (i.e., 6-7 mm)
* Absence of occlusal contacts or guidance on the cantilever extension at baseline
* Opposing dentition consisting of natural teeth or fixed or removable prosthetic restorations
* Availability of a periapical radiograph at baseline (i.e. FDPC delivery)
* Availability of PPD measurements (mm) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland)
* Availability of BoP measurements (%) (Lang et al., 1986) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland).
Exclusion Criteria:
* Untreated or active periodontal diseases
* Immediate implant placement (i.e., Type I implant placement according to Hämmerle et al., 2004)
* FDPCs in the aesthetic zone (i.e., replacement of maxillary or mandibular incisors)
* FDPCs supported by hollow-screw and hollow-cylinder implants
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05676268
Study Brief:
Protocol Section:
NCT05676268