Actively Recruiting
5-Years Multicentric Prospective Post-Market Clinical Follow-up Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece
Led by CeraRoot SL · Updated on 2024-03-01
652
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the survival rates of different ceramic dental implants in adults with missing or hopeless teeth. This observational study focuses on two types of CeraRoot ceramic implants: one-piece and two-piece (TL) models. The study aims to determine if there are significant differences in implant survival and to identify any complications associated with the procedures in these groups. The study involves patients from two dental centers in Barcelona, Spain, and Boulder, Colorado, USA. Participants will receive either one-piece or two-piece CeraRoot ceramic dental implants. These implants are specially designed for patients with metal allergies or chronic illnesses related to metal allergies. The study will follow patients for at least 12 months after enrollment to monitor implant survival and complications. During the study, researchers will collect information on implant survival rates and any complications occurring within one year after treatment. Participants will undergo dental assessments to evaluate implant status and oral health. The study's main outcome is the survival rate of the implants over 12 months or longer. This long-term follow-up helps understand the performance and safety of these ceramic dental implants in real-world clinical settings.
CONDITIONS
Brief Title
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of partial or total edentulism (missing teeth).
- Specially indicated for patients with metal allergies and chronic illness due to metal allergies.
- Adults aged 18 years or older.
- Fully grown men or women requiring dental reconstruction using dental implants.
- No contraindications for dental implant surgery.
You will not qualify if you...
- Presence of local or systemic contraindications for surgery.
- Poor oral hygiene.
- Health problems or physical/psychological conditions contraindicating oral surgery.
- Previously irradiated bone.
- Diabetes.
- Use of anticoagulant medication.
- Hemodynamic problems.
- Bruxism or parafunctional habits.
- Poor bone anatomy.
- Smoking.
- Uncontrolled periodontitis.
- Malocclusions.
- Temporomandibular joint (TMJ) problems.
- Diseases in the oral cavity.
- Pregnancy.
- Insufficient oral hygiene for adequate health.
- Insufficient bone quantity or quality.
- Remaining roots.
- Localized periodontal disease.
- Pathology in neighboring teeth.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or more from enrollment
Participants receive ceramic dental implants either one-piece or two-piece as part of routine dental reconstruction.
Approximately 6 post-operative visits
Duration - Up to 5 years
Participants are monitored for implant survival and complications following implantation.
Annual follow-up visits
Trial Site Locations
Total: 2 locations
1
Family Holistic Dentistry
Boulder, Colorado, United States, 80303
Actively Recruiting
2
CeraRoot CLINIC
Les Franqueses del Vallès, Barcelona, Spain, 08520
Actively Recruiting
Research Team
J
JOSEP Oliva, Dentist, DDS MSC
X
Xavi Oliva, DDS, MSC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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