5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece. (240101)

CeraRoot

Status: Enrolling

Conditions: Tooth Loss; Edentulism

Treatments: Device: dental implant

Study type: Observational

Funder types: Industry

Identifiers

NCT06287346

240101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 652 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

652 participants in 2 patient groups

One-piece

Description:

One-piece CeraRoot dental implants

Treatment:

Device: dental implant

Two-piece (TL)

Description:

Two-piece CeraRoot TL dental implants

Treatment:

Device: dental implant