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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT02877433
Eligibility Criteria:
Inclusion Criteria:
* Males and females with at least 18 years of age (including 18 years)
* Subject must have voluntarily signed the informed consent, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
* Fully edentulous (latest extraction in the mandible should be performed at least 12 weeks before implant placement) that can be restored with a complete denture
* Atrophic jaw bone in the posterior area, sufficient bone height and width to permit insertion of four short implants, 4 mm in regions of the first molar and second premolar on both sides and two standard length implants in the canine region
Exclusion Criteria:
* Patients with inadequate bone volume and/or quality
* Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
* Any contraindications for oral surgical procedures
* History of local irradiation therapy in the head / neck area
* Patients who smoke \>10 cigarettes per day or tobacco equivalents, chew tobacco or have ≥ 20 pack years
* Medical conditions requiring chronic high dose steroid therapy or high dose anti-resorptive treatment
* Subjects who have undergone administration of any investigational device within 30 days of enrollment 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
* Cognitive impairment that would interfere with the ability to perform adequate oral hygiene (assessed by the Ottawa 3DY scale)
* Patients with chronic pain
* Patients with HIV and/ or Hepatitis infection
* Severe bruxing or clenching habits
* Patients with inadequate oral hygiene or unmotivated for adequate home care (Denture Plaque Index (DPI) ≥ 5)
* Patients with drug or alcohol abuse
* Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy
* Major simultaneous augmentation procedures. Dehiscence of a vertical distance of more than 3 mm
* A woman who is pregnant or planning to become pregnant at any point during the study duration
Secondary Exclusion Criteria:
* Patients with inadequate bone volume and/or quality
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02877433
Study Brief:
Protocol Section:
NCT02877433