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NCT Number: NCT06287346

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CeraRoot CLINIC, Les Franqueses del Vallès, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • General Contraindications:
  • Local and Systemic contraindications for surgery.
  • Poor oral hygiene
  • Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.
  • Relative Contraindications:
  • Previously irradiated bone
  • diabetes
  • anticoagulant medication
  • hemodynamic problems
  • bruxism
  • Para functional habits
  • bad bone anatomy
  • smokers
  • none controlled periodontitis
  • malocclusions
  • TMJ problems
  • diseases in the oral cavity
  • pregnancy
  • insufficient oral hygiene for adequate health.
  • Local contraindications
  • insufficient bone quantity or quality
  • remaining of roots
  • localized periodontal disease
  • Any pathology in the neighboring teeth.

Treatment and study plan

dental implant

Device

ceramic dental implant

Primary outcomes

  1. Survival rate

    Time frame: 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 outcomes

  1. Complications

    Time frame: 1 year after treatment

    Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,

Study contacts

Contact information is provided by the study sponsor or research team.

JOSEP Oliva, Dentist, DDS MSC

CONTACT

[email protected]

800-485-1613

Xavi Oliva, DDS, MSC

CONTACT

[email protected]

800-485-1613

Sponsors and collaborators

Lead sponsor

CeraRoot SL

Industry

Registry information

Official study title

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

Acronym: 240101

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Mar 1, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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