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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-piece | One-piece CeraRoot dental implants |
| |
| Two-piece (TL) | Two-piece CeraRoot TL dental implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental implant | Device | ceramic dental implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | The implant is osseointegrated and in function in the patient's jaw without pain and no mobility. | From enrolment to the end of treatment 12 months or more. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss, | 1 year after treatment |
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Inclusion Criteria:
Exclusion Criteria:
General Contraindications:
Relative Contraindications:
Local contraindications
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The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JOSEP Oliva, Dentist, DDS MSC | Contact | 800-485-1613 | josep.oliva@cerarootclinic.com | |
| Xavi Oliva, DDS, MSC | Contact | 800-485-1613 | xavi.oliva@ceraroot.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Holistic Dentistry | Recruiting | Boulder | Colorado | 80303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | undefined |
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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
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| CeraRoot CLINIC | Recruiting | Les Franqueses del Vallès | Barcelona | 08520 | Spain |
|
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |