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Clinical Trials/NCT07119151
NCT07119151Not yet recruitingNot Applicable

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

Neodent0 sites94 target enrollmentStarted: September 1, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Neodent
Enrollment
94
Primary Endpoint
Implant success rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Implant success rate

Time Frame: From the implant loading to the 36-months of follow-up

Implant success rate (including survival as one of the criteria for success) of implants at 3 years after implant loading.

Secondary Outcomes

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

Investigators

Sponsor
Neodent
Sponsor Class
Industry
Responsible Party
Sponsor

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Multicentric Prospective Observational... | Clinical Trial