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

Last updated: February 29, 2024
Sponsor: CeraRoot SL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

dental implant

Clinical Study ID

NCT06287346
240101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical Diagnosis of partial or total edentulism.
  • Specially indicated for patients with metal allergies and chronic illness due to metalallergies.

Exclusion

Exclusion Criteria:

  1. General Contraindications:
  2. Local and Systemic contraindications for surgery.
  3. Poor oral hygiene
  4. Patients with health problems, disease or any physical or psychological conditionto which an oral surgery may be contraindicated.
  5. Relative Contraindications:
  6. Previously irradiated bone
  7. diabetes
  8. anticoagulant medication
  9. hemodynamic problems
  10. bruxism
  11. Para functional habits
  12. bad bone anatomy
  13. smokers
  14. none controlled periodontitis
  15. malocclusions
  16. TMJ problems
  17. diseases in the oral cavity
  18. pregnancy
  19. insufficient oral hygiene for adequate health.
  20. Local contraindications
  21. insufficient bone quantity or quality
  22. remaining of roots
  23. localized periodontal disease
  24. Any pathology in the neighboring teeth.

Study Design

Total Participants: 652
Treatment Group(s): 1
Primary Treatment: dental implant
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
January 01, 2030

Study 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.

Connect with a study center

  • CeraRoot CLINIC

    Les Franqueses del Vallès, Barcelona 08520
    Spain

    Active - Recruiting

  • Family Holistic Dentistry

    Boulder, Colorado 80303
    United States

    Active - Recruiting

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