Comparing one-piece and two-piece ceramic dental implants for tooth loss
5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
This study is testing whether one-piece or two-piece ceramic dental implants work better for adults with missing teeth and if there are any problems with each type.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 652 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CeraRoot SL Industry-sponsored |
| Locations | 2 sites (Boulder, Colorado and 1 other locations) |
| Trial ID | NCT06287346 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the survival rates of one-piece versus two-piece ceramic dental implants in patients with missing or hopeless teeth. It will assess the performance of various CeraRoot ceramic implant models and identify any complications associated with each type. The study will involve patients from two dental centers located in Barcelona, Spain, and Boulder, Colorado, USA. Participants will be fully-grown individuals requiring dental reconstruction and who have no contraindications, particularly those with metal allergies.
Who should consider this trial
Good fit: Ideal candidates include fully-grown patients with partial or total edentulism, especially those with metal allergies.
Not a fit: Patients with significant health issues, poor oral hygiene, or contraindications for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective type of ceramic dental implant, improving outcomes for patients with tooth loss.
How similar studies have performed: While there have been studies on dental implants, this specific comparison of one-piece versus two-piece ceramic implants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: 1. General Contraindications: 1. Local and Systemic contraindications for surgery. 2. Poor oral hygiene 3. Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated. 2. Relative Contraindications: 1. Previously irradiated bone 2. diabetes 3. anticoagulant medication 4. hemodynamic problems 5. bruxism 6. Para functional habits 7. bad bone anatomy 8. smokers 9. none controlled periodontitis 10. malocclusions 11. TMJ problems 12. diseases in the oral cavity 13. pregnancy 14. insufficient oral hygiene for adequate health. 3. Local contraindications 1. insufficient bone quantity or quality 2. remaining of roots 3. localized periodontal disease 4. Any pathology in the neighboring teeth.
Where this trial is running
Boulder, Colorado and 1 other locations
- Family Holistic Dentistry — Boulder, Colorado, United States (Recruiting)
- CeraRoot CLINIC — Les Franqueses del Vallès, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: JOSEP Oliva, Dentist, DDS MSC
- Email: josep.oliva@cerarootclinic.com
- Phone: 800-485-1613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.