5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.

5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06287346

Acronym

240101

Enrollment

652

Registered

2024-03-01

Start date

2024-01-01

Completion date

2030-01-01

Last updated

2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulism, Tooth Loss

Keywords

dental implant, ceramic dental implant, zirconia implant, y-tzp, metal-free

Brief summary

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

DEVICEdental implant

ceramic dental implant

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Survival rate	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.

Secondary

Measure	Time frame	Description
Complications	1 year after treatment	Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,

Countries

Spain, United States

Contacts

Primary ContactJOSEP Oliva, Dentist, DDS MSC

josep.oliva@cerarootclinic.com800-485-1613

Backup ContactXavi Oliva, DDS, MSC

xavi.oliva@ceraroot.com800-485-1613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026