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

February 29, 2024 updated by: CeraRoot SL

5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

652

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Les Franqueses del Vallès, Barcelona, Spain, 08520
        • Recruiting
        • CeraRoot CLINIC
        • Contact:
        • Contact:
        • Principal Investigator:
          • JOSEP OLIVA-OCHOA, DDS MSC
        • Sub-Investigator:
          • XAVIER OLIVA-OCHOA, DDS MSC
        • Sub-Investigator:
          • CARLA OLIVA-PORTA, STUDENT
        • Sub-Investigator:
          • ARNAU OLIVA-PORTA, STUDENT
  • United States
    • Colorado
      • Boulder, Colorado, United States, 80303
        • Recruiting
        • Family Holistic Dentistry
        • Contact:
        • Principal Investigator:
          • CARMEN BURKE, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
One-piece
One-piece CeraRoot dental implants
Device: dental implant
ceramic dental implant
Two-piece (TL)
Two-piece CeraRoot TL dental implants
Device: dental implant
ceramic dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrolment to the end of treatment 12 months or more.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1 year after treatment
Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,
1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CeraRoot SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • undefined

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

at the end of the study the results will be published including, method and results survival rates and complications rate. For this reason no need to share any other information

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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