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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT02699866
Eligibility Criteria:
Inclusion Criteria:
* Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.
* Patients must be males or females who are a minimum of 18 years of age.
* Patients with a minimum of 4 weeks history of edentulism in the study area, minimal interdental space and in need of a single tooth replacement with a dental implant central and lateral incisors in the mandible and lateral incisors in the maxilla (Federation Dentaire Internationale (FDI) positions 12, 22, 31, 32, 41 or 42).
* Presence of natural tooth or implants adjacent to the study implant position (single tooth gap).
* Patients with complete soft tissue coverage of the socket at implant placement.
Exclusion Criteria:
* Patients with inadequate bone volume and / or quality or metabolic bone disorder.
* Patients with local root remnants.
* Patients with inadequate wound healing capacity.
* Patients with not completed maxillary and mandibular growth.
* Patients with serious internal medical problems, uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders.
* Patients with poor general state of health.
* Patients with drug or alcohol abuse.
* Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy.
* Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
* A woman who is pregnant or planning to become pregnant at any point during the study duration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02699866
Study Brief:
Protocol Section:
NCT02699866