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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT01720420
Eligibility Criteria:
Inclusion Criteria:
1. The subject is at least 18 years of age (or age of consent) and has passed secession of growth
2. The subject is not older than 70 years
3. Obtained informed consent from the subject
4. Edentulous mandible or maxilla providing sufficient bone whereas removable NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an appropriate treatment solution
5. The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed or extraction sites implants with a length of at least 10mm
6. The implant site is free from infection and extraction remnants
7. Implants will be placed in healed or extractions sites, defined as a site with 8 weeks of healing following tooth extraction, respectively 6 months after major bone augmentation or soft tissue grafting
8. Good gingival / periodontal / periapical status of opposing teeth/implants
9. The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based
10. The subjects as well as the implant site(s) fulfill the criteria for early loading (6 weeks until 3 months after implant placement)
11. The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
12. The subject is available for the 5-year term of the investigation
13. The subject is compliant with good oral hygiene
Exclusion Criteria:
1. The subject is not able to give her/his informed consent of participating
2. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure
3. Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history
4. Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
5. Alcohol or drug abuse as noted in subject records or in subject history
6. Smoking of \>10 cigarettes/day
7. Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
8. Pathologic occlusion, e.g. severe bruxism or other destructive habits
9. Lack of opposing dentition or unstable occlusion
10. Ongoing infections, endodontic or periodontal problems in opposing teeth or implants
11. Subject shows an unacceptable oral hygiene
12. Subject has allergic or adverse reactions to the restorative material.
13. Bone augmentation of more than 3mm vertical height performed less than 3 months prior to planned implant placement.
14. Long-term bis-phosphonate therapy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01720420
Study Brief:
Protocol Section:
NCT01720420