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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT02186912
Eligibility Criteria:
The subject is at least 18 years of age (or age of consent) and has passed secession of growth
Obtained informed consent from the subject
Edentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM Implant bridge on four (4) implants is regarded as an appropriate treatment solution
The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed sites implants with a length of at least 8 mm
The implant site is free from infection and extraction remnants Implants will be placed in healed sites.
Good gingival / periodontal / peri-apical status of opposing teeth/implants
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
The subjects as well as the implant site(s) fulfill the criteria for immediate loading.
The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation
Exclusion Criteria:
The subject is not able to give her/his informed consent of participating
Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure
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 Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
Alcohol or drug abuse as noted in subject records or in subject history Smoking of \>10 cigarettes/day
Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
Pathologic occlusion, e.g. severe bruxism or other destructive habits
Lack of opposing dentition or unstable occlusion
Ongoing infections, endodontic or periodontal problems in opposing teeth or implants
Subject shows an unacceptable oral hygiene
Subject has allergic or adverse reactions to the restorative material.
Bone augmentation of more than 3mm vertical height performed less than 6 months prior to planned implant placement.
Bis-phosphonate therapy
Implant insertion torque is \<35 Ncm or \>70 Ncm
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02186912
Study Brief:
Protocol Section:
NCT02186912