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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT02163395
Eligibility Criteria:
Inclusion Criteria:
* Subject must have voluntary signed the informed consent and the data protection consent form before any study related action
* Males and females with at least 18 years of age (including 18 years)
* Implant placement planned in the maxilla or mandible
* The missing tooth site must have a tooth with a natural root
* Substantially healed and augmented extraction sockets (minimal 8 weeks)
* Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position
Exclusion Criteria:
Pre-surgical exclusion criteria:
* Systemic disease that would interfere with dental implant therapy
* Any contraindications for oral surgical procedures
* Mucosal diseases
* History of local irradiation therapy
* Current untreated periodontitis or gingivitis
* Any untreated endodontic lesions
* Probing pocket depth of \> or = 4 mm on one of the teeth immediately adjacent to the dental implant site
* Severe bruxing or clenching habits
* Patients with inadequate oral hygiene or unmotivated for adequate home care
* Patients who smoke \>10 cigarettes per day or tobacco equivalents or chew tobacco
* Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
* 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
* Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
* Pregnant women at screening
Secondary exclusion criteria at or after implant surgery:
* Lack of primary stability of the implant (hand testing directly after surgery)
* Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration)
* Major simultaneous augmentation procedures (at surgery)
* X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02163395
Study Brief:
Protocol Section:
NCT02163395