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Not yet recruiting NCT07119151

Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System

— Observational Edentulism Dental Implant Atrophy of Edentulous Alveolar Ridge Atrophy of Edentulous Mandibular Alveolar Ridge

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dental Implant.
Who it may be relevant to
Registry conditions: Edentulism, Dental Implant, Atrophy of Edentulous Alveolar Ridge, Atrophy of Edentulous Mandibular Alveolar Ridge. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a post-market prospective observational study to prospectively collect clinical data to confirm the long-term safety and clinical performance of implants and abutments Helix Short in a daily dental practice setting, by means of success and survival rates of these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the IFU, identify and analyze emerging risks on the basis of factual evidence, and ensure the continued acceptability of the benefit-risk ratio with the intent to verify that the intended purpose is correct for all JJGC products involved in the procedure that get in contact with the patient.

Interventions

  • Device Dental Implant
    Dental Implant placement and loading.

Primary outcome measures

  • Implant success rate [Time frame: From the implant loading to the 36-months of follow-up]
Secondary outcome measures (12)
  • Implant survival rate [Time frame: From the implant loading to the 36-months of follow-up]
  • Prosthetic survival and success rates [Time frame: From the implant loading to 36-months of follow-up]
  • Change in peri-implant bone level [Time frame: From the implant loading to 36-months of follow-up]
  • Soft tissue assessment - Visible Plaque [Time frame: From the implant loading to 36-months of follow-up]
  • Evaluation of the crown/implant ratio [Time frame: From the implant loading to 36-months of follow-up]
  • Risk factors for Implant Loss [Time frame: From the enrollment to 36-months of follow-up]
  • Type of load and time for final prosthesis [Time frame: From the implant placement to 36-months of follow-up]
  • Patient satisfaction [Time frame: From the enrollment to 36-months of follow-up.]
  • Clinician satisfaction with all devices used and procedures [Time frame: From the implant placement to 36-months of follow-up.]
  • Adverse events and residual risks related to the implant, prosthetic component, and prosthesis. [Time frame: From the enrollment to 36-months of follow-up.]
  • Soft tissue assessment - Marginal Bleeding Indexes [Time frame: From the implant loading to 36-months of follow-up]
  • Soft tissue assessment - Bleeding on probing [Time frame: From the implant loading to 36-months of follow-up]

Eligibility criteria

Inclusion criteria

  • Patients with atrophic maxilla and mandible, who need of one or more dental implants with opposing dentition (natural teeth or teeth/implant-supported fixed restorations) and who qualify for placement of Helix Short implants.
  • Collaborative patient.
  • Patient with opposing dentition (natural teeth or fixed and/or removable restorations)

Exclusion criteria

  • Contraindication according to the IFU: This product is contraindicated for patients who show signs of allergy or hypersensitivity to the chemical components of titanium. Implants with a length of 4 mm are contraindicated for single and overdenture rehabilitations, and they are contraindicated for total and multiple restorations when not associated with implants with lengths greater than or equal to 5.5 mm.
  • Patients with periodontal disease, severe alcohol/tobacco consumption, bruxism, high use of bisphosphonates or proton pump inhibitors (PPI), radiotherapy to the neck and head in the last 3 years, uncontrolled systemic diseases.
  • Pregnant patient.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07119151 · CS.O.014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗