5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
CeraRoot SL
Summary
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: * Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant? * What are the complications associated to the procedure and differences between the two groups.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical Diagnosis of partial or total edentulism. * Specially indicated for patients with metal allergies and chronic illness due to metal allergies. Exclusion Criteria: 1. General Contraindications: 1. Local and Systemic contraindications for surgery. 2. Poor oral hygiene 3. Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated. 2. Relative Contraindications: 1. Previously irradiated bone 2. diabetes 3. anticoagulant medication 4. hemodynamic problems 5. bruxism 6…
Interventions
- Devicedental implant
ceramic dental implant
Locations (2)
- Family Holistic DentistryBoulder, Colorado
- CeraRoot CLINICLes Franqueses del Vallès, Barcelona