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 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT02175550
Eligibility Criteria:
Inclusion Criteria:
* Obtained informed consent from the subject.
* The subject shall be at least 18 years of age and have passed secession of growth
* The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems. (The patient is committed to the study
* The subject requires single unit implant restoration in the anterior maxilla (FDI 15-25); (ADA 4-13)
* The tooth at the planned study site of interest is extracted or lost at least 2 months before the date of implantation
* Healthy implantation site
* Full mouth bleeding on probing (FMBoP) and full mouth plaque index (FMPI) are both lower or equal to 25%
* The subject shall have a favorable and stable occlusal relationship
* Natural roots are adjacent to the implant site
* Maximum two single unit restorations per patient
* The patient is suitable for a 1-stage surgical procedure
* The patient is suitable for immediate temporization without full occlusal loading
* Subject's acceptance of the scheduled program of clinical and radiographic analysis and maintenance.
Exclusion Criteria:
* Insufficient bone volume at the implant site for placing a NobelReplace CC NP 3.5 implant with a length of at least 8 mm.
* Major bone augmentation procedure at the site of implantation
* Primary stability of the placed implant is ≤35Ncm
* Implant insertion of ≥ 45Ncm
* Acute, untreated periodontitis
* Health conditions, which do not permit the surgical treatment
* Any disorders in the planned implant area such as previous tumors, chronic one disease (such as rheumatoid disease)
* Infections in adjacent tissue of the planned implantation site
* Previous oro-maxillo-facial radiotherapy
* Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
* Alcohol or drug abuse as noted in subject records or in subject history
* Heavy smoking (\>10 cigarettes/day)
* Uncontrolled diabetes
* Severe bruxism or other destructive habits
* Pregnant or lactating woman
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02175550
Study Brief:
Protocol Section:
NCT02175550