An observational study in Edentulism and Tooth Loss, sponsored by CeraRoot SL. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by CeraRoot SL · Observational
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question[s] it aims to answer are:
The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).
The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 652 is above the median of 80 across 40 observational studies indexed under Tooth Loss.
Browse Tooth Loss studies →CeraRoot SL is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
General :
Relative Contraindications:
Local contraindications
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One-piece CeraRoot dental implants
Device: dental implant
Two-piece CeraRoot TL dental implants
Device: dental implant
ceramic dental implant
Survival rate
The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.
Time frame: From enrolment to the end of treatment 12 months or more.
Complications
Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,
Time frame: 1 year after treatment
Plan to share: No — at the end of the study the results will be published including, method and results survival rates and complications rate. For this reason no need to share any other information
Started Jan 2024 (actual). Primary completion is estimated for Jan 2029, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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CeraRoot SL