Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07119151

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

dental implant

Device

Dental Implant placement and loading.

Primary outcomes

  1. 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

  1. Implant survival rate

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

    Implant survival rate

  2. Prosthetic survival and success rates

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

    Prosthetic results

  3. Change in peri-implant bone level

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

    Evaluating bone loss

  4. Soft tissue assessment - Visible Plaque

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

    Visible plaque index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting visible plaque.

  5. Evaluation of the crown/implant ratio

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

    Evaluation of the crown/implant ratio

  6. Risk factors for Implant Loss

    Time frame: From the enrollment to 36-months of follow-up

    Risk factors for implant loss will be assessed performing statistical analysis between implants losses and characteristics of these losses (implant and procedures' characteristics).

  7. Type of load and time for final prosthesis

    Time frame: From the implant placement to 36-months of follow-up

    If immediate or late loading.

  8. Patient satisfaction

    Time frame: From the enrollment to 36-months of follow-up.

    Patient satisfaction assessment through (Oral Health Impact Profile-14) questionnaire. It is made of 14 questions to be answered through a set of Likert scale. The final score is calculated based on the answers for each question, and it is ranged from 0 to 56. The highest score indicates a greater negative impact of oral health on a person's well-being. The questions include seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and social disadvantage. The questionnaire will be applied in different times of follow-up during the study.

  9. Clinician satisfaction with all devices used and procedures

    Time frame: From the implant placement to 36-months of follow-up.

    Clinician satisfaction assessment through a questionnaire about implant placement and rehabilitation outcomes, and the answers through a visual analogue scale (VAS) from 1 to 10. The highest scores means better outcome.

  10. Adverse events and residual risks related to the implant, prosthetic component, and prosthesis.

    Time frame: From the enrollment to 36-months of follow-up.

    Monitoring of adverse events, including implant and prothesis loss to evaluate their association with implant's and patient's charactheristics.

  11. Soft tissue assessment - Marginal Bleeding Indexes

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

    Marginal bleeding index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting marginal bleeding.

  12. Soft tissue assessment - Bleeding on probing

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

    Bleeding on probing will be assessed as present or absent, using a periodontal probe to the bottom of the clinical sulcus, in the buccal surface of each implant site. Bleeding will be considered positive if it occurs within 10 to 15 seconds after probing.

  13. Soft tissue assessment - Keratinized gingiva

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

    Calibrated probes of 1, 2, 3, 5, 7, and 10 mm will be used to measure the range of keratinized gingiva as the distance from the gingival margin to the mucogingival junction, at the center of the buccal surface. The thickness of the keratinized tissue will be assessed and categorized as thick or thin. This assessment will be based on the transparency of the same periodontal probe through the gingival margin during the probing of the sulcus in the mid-buccal region. If the outline of the underlying periodontal probe could be seen through the gingiva, it was classified as thin (score: 0); otherwise, it was classified as thick (score: 1)

Sponsors and collaborators

Lead sponsor

Neodent

Industry

Collaborators

  • Faculdade ILAPEO
  • Federal University of Uberlandia
  • UNESP, Câmpus de Araraquara

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.