5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCeraRoot SL
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical Diagnosis of partial or total edentulism.
Specially indicated for patients with metal allergies and chronic illness due to metal allergies.
Disqualifiers
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.
Previously irradiated bone
Trial population
The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
dental implant
Deviceceramic dental implant
Treatment groups
652 Participants
are divided into 2 treatment groupsGroup A: One-piece1 intervention
Group B: Two-piece (TL)1 intervention
Trial outcomes
Primary outcomes
1
Survival rate
The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.
Time frame
From enrolment to the end of treatment 12 months or more.Secondary outcomes
1
Complications
Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,
Time frame
1 year after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov