5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dental implant.
- Who it may be relevant to
- Registry conditions: Edentulism, Tooth Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
Overview
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.
Detailed description
The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).
The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
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.]
Secondary outcome measures (1)
- Complications [Time frame: 1 year after treatment]
Eligibility criteria
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
- diabetes
- anticoagulant medication
- hemodynamic problems
- bruxism
- Para functional habits
- bad bone anatomy
- smokers
- none controlled periodontitis
- malocclusions
- TMJ problems
- diseases in the oral cavity
- pregnancy
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Family Holistic Dentistry — Boulder
Spain · 1 center
- CeraRoot CLINIC — Les Franqueses del Vallès
Publications
- undefined
Identifiers
NCT: NCT06287346 · 240101