5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Edentulism
- Sponsor
- CeraRoot SL
- Enrollment
- 652
- Locations
- 2
- Primary Endpoint
- Survival rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
- •General Contraindications:
- •Local and Systemic contraindications for surgery.
- •Poor oral hygiene
- •Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.
- •Relative Contraindications:
- •Previously irradiated bone
- •anticoagulant medication
- •hemodynamic problems
- •Para functional habits
- •bad bone anatomy
Outcomes
Primary Outcomes
Survival rate
Time Frame: From enrolment to the end of treatment 12 months or more.
The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.
Secondary Outcomes
- Complications(1 year after treatment)