NCT06287346Recruiting

5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.

CeraRoot SL

Start Date

1/1/2024

Completion Date

1/1/2030

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.

Detailed 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® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

Eligibility Criteria

Age Range: 18 years to No maximum

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. Para functional habits 7. bad bone anatomy 8. smokers 9. none controlled periodontitis 10. malocclusions 11. TMJ problems 12. diseases in the oral cavity 13. pregnancy 14. insufficient oral hygiene for adequate health. 3. Local contraindications 1. insufficient bone quantity or quality 2. remaining of roots 3. localized periodontal disease 4. Any pathology in the neighboring teeth.

Interventions

DEVICE

dental implant

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Conditions

EdentulismTooth Loss

Locations

Family Holistic Dentistry

Boulder, Colorado 80303

United States

CeraRoot CLINIC

Les Franqueses del Vallès, Barcelona 08520

Spain