A 5-year Clinical Evaluation Study on NobelReplace Conical Connection Implants (NCT02175550) | Clinical Trial Compass
CompletedNot Applicable
A 5-year Clinical Evaluation Study on NobelReplace Conical Connection Implants
99 participantsStarted 2011-03
Plain-language summary
A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The implant is a two piece design to allow both one- and two- stage surgical procedures. The entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to promote and maintain primary stability, which later on leads to secondary stability.
NR CC implants are used as the foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to an entire arch of bridgework. The implants are also intended as retentive elements for overdenture applications.
The present study is designed to evaluate, after the insertion of the NR CC, the marginal bone levels and bone remodelling at the implant sites over various time points up to 5 years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are as well evaluated together with implant success and survival rate.
Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this clinical investigation will demonstrate clinical safety and reliability of the NR CC using different treatment options.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone levels and bone remodeling at the implant sites