NCT06287346 · CeraRoot SL
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
(240101)
What this study is about
The goal of this group of participants observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth .
View original scientific description
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.
Interventions
DEVICE
dental implant
ceramic dental implant
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- none controlled periodontitis
- malocclusions
- TMJ problems
- diseases in the oral cavity
- insufficient oral hygiene for adequate health.
- Local contraindications
- insufficient bone quantity or quality
- remaining of roots
- localized periodontal disease
- Any pathology in the neighboring teeth.
Where
- Boulder, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 1, 2024 · Source of record for eligibility and locations