5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
240101
5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
1 other identifier
observational
652
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 23, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
March 1, 2024
February 1, 2024
5 years
February 23, 2024
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Complications
1 year after treatment
Study Arms (2)
One-piece
One-piece CeraRoot dental implants
Two-piece (TL)
Two-piece CeraRoot TL dental implants
Interventions
Eligibility Criteria
The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).
You may qualify if:
- Clinical Diagnosis of partial or total edentulism.
- Specially indicated for patients with metal allergies and chronic illness due to metal allergies.
You may not qualify if:
- 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
- diabetes
- anticoagulant medication
- hemodynamic problems
- bruxism
- Para functional habits
- bad bone anatomy
- smokers
- none controlled periodontitis
- malocclusions
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CeraRoot SLlead
Study Sites (2)
Family Holistic Dentistry
Boulder, Colorado, 80303, United States
CeraRoot CLINIC
Les Franqueses del Vallès, Barcelona, 08520, Spain
Related Publications (1)
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BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2024
First Posted
March 1, 2024
Study Start
January 1, 2024
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2030
Last Updated
March 1, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
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