N/A
N=98
PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Tooth Loss · Ceramic Implant
Bottom Line
View on ClinicalTrials.gov: NCT04598776 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Implants That Survived — 157; 5 implants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CeraRoot SL
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Implants That Survived |
157; 5 | — |
| SECONDARY Number of Implants With Surgical Complications (SC) |
— | — |
| SECONDARY Number of Implants With Before Loading Implants Complications (BLIC) |
— | — |
| SECONDARY Number of Implants With After Loading Implants Complications (ALIC) |
1; 2; 1; 1 | — |
| SECONDARY Number of Units With Prosthetic Complications (PC) |
— | — |
Summary
The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.
Eligibility Criteria
Inclusion Criteria
- Patients that have received the studied ceramic implant after 27 August 2020.
- Patients of CeraRoot Clinic (Barcelona)
- Age >18
- Single or multiple missing or hopeless teeth
Exclusion Criteria
- Smokers.
- The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- Untreated periodontal conditions
Data sourced from ClinicalTrials.gov (NCT04598776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.