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Search / Trial NCT06287346

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

Launched by CERAROOT SL · Feb 29, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Dental Implant Ceramic Dental Implant Zirconia Implant Y Tzp Metal Free

ClinConnect Summary

This clinical trial is studying two types of ceramic dental implants—one-piece and two-piece—used for patients who have lost teeth or have teeth that cannot be saved. The main goal is to see if there is a difference in how long each type of implant lasts and to identify any complications that might arise from the procedures. This research is particularly important for patients who have allergies to metal or chronic health issues related to metal.

To participate in the trial, you need to be diagnosed with either partial or total tooth loss and have specific metal allergies. However, there are some conditions that may prevent you from being eligible, such as having ongoing health problems, poor oral hygiene, or certain dental issues. If you join the study, you can expect close monitoring to ensure your safety and to help gather important information on the effectiveness of these dental implants. This trial is currently looking for participants aged between 65 and 74, and anyone interested should discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility 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.

About Ceraroot Sl

Ceraroot SL is a pioneering clinical trial sponsor dedicated to advancing innovative medical solutions through rigorous research and development. With a focus on enhancing patient care, Ceraroot SL specializes in conducting high-quality clinical trials that adhere to the highest ethical standards and regulatory requirements. The organization collaborates with leading healthcare professionals and institutions to evaluate the safety and efficacy of novel therapies, ensuring that their findings contribute meaningfully to the medical community and improve patient outcomes. Committed to transparency and excellence, Ceraroot SL strives to foster trust and collaboration in the pursuit of groundbreaking healthcare advancements.

Locations

Les Franqueses Del Vallès, Barcelona, Spain

Boulder, Colorado, United States

Patients applied

PS

CW

AG

ER

4 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported