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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

652 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2030-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Edentulism Tooth Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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One-piece

One-piece CeraRoot dental implants

dental implant

Intervention Type DEVICE

ceramic dental implant

Two-piece (TL)

Two-piece CeraRoot TL dental implants

dental implant

Intervention Type DEVICE

ceramic dental implant

Interventions

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dental implant

ceramic dental implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No