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

NCT07119151 | Not Yet Recruiting DMC

• 1 other identifier: CS.O.014
• Study Type: observational
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Edentulism; Dental Implant; Atrophy of Edentulous Alveolar Ridge; Atrophy of Edentulous Mandibular Alveolar Ridge; Atrophy of Edentulous Maxillary Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• Implant success rate

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

  From the implant loading to the 36-months of follow-up

Secondary Outcomes (13)

• Implant survival rate

  From the implant loading to the 36-months of follow-up

• Prosthetic survival and success rates

  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

• Evaluation of the crown/implant ratio

  From the implant loading to 36-months of follow-up

Study Arms (1)

Treatment

Patients with maxillary and mandible atrophy in need of one or more dental implants and who were evaluated as suitable for the installation of Helix Short implants.

Device: Dental Implant

Interventions

Dental Implant DEVICE

Dental Implant placement and loading.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neodent: lead
• Federal University of Uberlandia: collaborator
• UNESP, Câmpus de Araraquara: collaborator
• Faculdade ILAPEO: collaborator

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08