EdentulismNCT07119151
Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
An observational study of Edentulism and Dental Implant, run by Neodent.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulism, Dental Implant, Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- Dental Implant
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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
- Being tested
- Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantDevice
Dental Implant placement and loading.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dental Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success rate
Implant success rate (including survival as one of the criteria for success) of implants at 3 years after implant loading.
Measured: From the implant loading to the 36-months of follow-up
Secondary outcomes (13)
Implant survival rate
Implant survival rate
Measured: From the implant loading to the 36-months of follow-up
Prosthetic survival and success rates
Prosthetic results
Measured: From the implant loading to 36-months of follow-up
Change in peri-implant bone level
Evaluating bone loss
Measured: From the implant loading to 36-months of follow-up
Soft tissue assessment - Visible Plaque
Visible plaque index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting visible plaque.
Measured: From the implant loading to 36-months of follow-up
Evaluation of the crown/implant ratio
Evaluation of the crown/implant ratio
Measured: From the implant loading to 36-months of follow-up
Risk factors for Implant Loss
Risk factors for implant loss will be assessed performing statistical analysis between implants losses and characteristics of these losses (implant and procedures' characteristics).
Measured: From the enrollment to 36-months of follow-up
Type of load and time for final prosthesis
If immediate or late loading.
Measured: From the implant placement to 36-months of follow-up
Patient satisfaction
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.
Measured: From the enrollment to 36-months of follow-up.
Clinician satisfaction with all devices used and procedures
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.
Measured: From the implant placement to 36-months of follow-up.
Adverse events and residual risks related to the implant, prosthetic component, and prosthesis.
Monitoring of adverse events, including implant and prothesis loss to evaluate their association with implant's and patient's charactheristics.
Measured: From the enrollment to 36-months of follow-up.
Soft tissue assessment - Marginal Bleeding Indexes
Marginal bleeding index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting marginal bleeding.
Measured: From the implant loading to 36-months of follow-up
Soft tissue assessment - Bleeding on probing
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.
Measured: From the implant loading to 36-months of follow-up
Soft tissue assessment - Keratinized gingiva
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)
Measured: From the implant loading to 36-months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Uberlandia, UNESP, Câmpus de Araraquara, Faculdade ILAPEO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119151
- Sponsor's protocol ID
- CS.O.014
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
- ClinicalTrials.gov ID
- NCT07119151
- Acronym / sponsor ID
- CS.O.014
- Conditions
- Edentulism, Dental Implant, Atrophy of Edentulous Alveolar Ridge, Atrophy of Edentulous Mandibular Alveolar Ridge, Atrophy of Edentulous Maxillary Alveolar Ridge
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Uberlandia, UNESP, Câmpus de Araraquara, Faculdade ILAPEO
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Dental ImplantPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental ImplantDental Implant placement and loading. | Device | Treatment |
Primary outcome
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.
13 secondary outcomes
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
Soft tissue assessment - Keratinized gingiva
Time frame: From the implant loading to 36-months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Related trials for Edentulism
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism and Dental Implant, run by Neodent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success rate (time frame: From the implant loading to the 36-months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.