Jaw, EdentulousNCT03812276
Neodent Implantable Devices of GM Line
An observational study of Jaw, Edentulous and Jaw, Edentulous, Partially, run by Neodent at 2 sites in Brazil.
Trial summary
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities. The objective of the study is to prospectively collect clinical data to confirm the long-term safety and clinical performance of Acqua GM Helix… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Jaw, Edentulous, Partially
- What is being tested?
- Dental Implants
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 2 sitesBrazil
- Study dates
- 14 Feb 2019to 28 Jan 2023
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 18 years of age or older who are in need of and who qualify for dental implant placement with GM Helix implants at the involved study centers. Patients that give written informed consent to participate in this clinical study.
Who may be able to join
- 18 years of age or older;
- Need of one or more dental implants;
- Qualify for placement of Neodent GM Helix implants.
Who cannot join
- As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied:
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium alloy;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume or quality;
- Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
- Insufficient oral hygiene;
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- Incomplete jawbone growth;
- Patient uncooperative and not motivated;
- Abuse of drugs or alcohol;
- Psychosis;
- Prolonged functional disorders which resist any treatment with medications;
- Xerostomia;
- Weakened immunological system;
- Diseases which require the use of steroids;
- Uncontrolled endocrinological diseases;
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Curitiba, Paraná, 80710-150
Universidade Positivo
Curitiba, Paraná, 81280-330
About this study
Official title: Prospective Observational Study of Neodent Implantable Devices of GM Line
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities.
The objective of the study is to prospectively collect clinical data to confirm the long-term safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in daily dental practice setting, by means of success and survival rates of these devices.
Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (instructions for use). patients will be followed for 36 months after implant placement.
Read the detailed description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.
The sample will be prospectively and consecutively selected and will consist of patients who are 18 years of age or older, who are in need of one or more dental implants and who qualify for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.
Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants may be placed in a single subject. Implants will be placed 2mm below the alveolar ridge.
The selection of the prosthetic component and loading protocol (late or immediate) will be conducted according to the need of each subject and to the manufacturer's instructions (IFU). Thus, implant immediate loading may be performed (at the discretion of the surgeon) when primary stability reach at least 32 N.cm and the patient present physiological occlusion.
Data concerning the studied variables will be collected by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implant(s) placement; TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement. A visit window of more or less one month is eligible for each of the planned intervals.
Standardized digital periapical radiographs, computed tomography scans and photographs will be obtained in an usual daily practice frequency, as determined by the investigator.
- Conditions
- Jaw, Edentulous, Jaw, Edentulous, Partially
- Being tested
- Dental Implants
- Keywords
- Dental Implants
- Medical subject headings
- Jaw, Edentulous, Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantsDevice
Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Neodent Acqua GM Helix dental implants will be placed. Multiple implants may be placed in a single subject. Receives: Device: Dental Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival and success rates
Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
Measured: 36 months after implant placement
Secondary outcomes (5)
Implant survival and success rates
Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
Measured: 6, 12 and 24 months after implant placement
Prosthetic survival and success rates
Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition. Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period.
Measured: 12, 24 and 36 months after implant placement
Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire
The Portuguese translation of OHIP-14 [18,19] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Scores will range from 0 (absence of negative impacts on oral health) to 28 (high frequency of negative impacts on oral health).
Measured: 6, 12, 24 and 36 months after implant placement
Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire
The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction. The clinician will be instructed to mark the position considered to best represent their degree of general satisfaction with patient treatment. The score will be measured in centimeters from the left end of the line to the marked point.
Measured: Implant placement, 12, 24 and 36 months after implant placement
Rate of adverse events related to the implant, prosthesis, surgery and oral health
Determined by inquiring with the patient and clinical evaluation.
Measured: Implant placement, 6, 12, 24 and 36 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start14 Feb 2019
- Primary completion10 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larissa Trojan, PhD, Study chair, Neodent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812276
- Sponsor's protocol ID
- CS.O.002
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Neodent Implantable Devices of GM Line
- ClinicalTrials.gov ID
- NCT03812276
- Acronym / sponsor ID
- CS.O.002
- Conditions
- Jaw, Edentulous, Jaw, Edentulous, Partially
- Keywords
- Dental Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 23 Jan 2019 (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.
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities.
The objective of the study is to prospectively collect clinical data to confirm the long-term safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in daily dental practice setting, by means of success and survival rates of these devices.
Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (instructions for use). patients will be followed for 36 months after implant placement.
Detailed description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.
The sample will be prospectively and consecutively selected and will consist of patients who are 18 years of age or older, who are in need of one or more dental implants and who qualify for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.
Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants may be placed in a single subject. Implants will be placed 2mm below the alveolar ridge.
The selection of the prosthetic component and loading protocol (late or immediate) will be conducted according to the need of each subject and to the manufacturer's instructions (IFU). Thus, implant immediate loading may be performed (at the discretion of the surgeon) when primary stability reach at least 32 N.cm and the patient present physiological occlusion.
Data concerning the studied variables will be collected by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implant(s) placement; TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement. A visit window of more or less one month is eligible for each of the planned intervals.
Standardized digital periapical radiographs, computed tomography scans and photographs will be obtained in an usual daily practice frequency, as determined by the investigator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Dental ImplantsNeodent Acqua GM Helix dental implants will be placed. Multiple implants may be placed in a single subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older who are in need of and who qualify for dental implant placement with GM Helix implants at the involved study centers. Patients that give written informed consent to participate in this clinical study.
Key inclusion criteria (3 listed)
- 18 years of age or older;
- Need of one or more dental implants;
- Qualify for placement of Neodent GM Helix implants.
Key exclusion criteria (16 listed)
- As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied:
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium alloy;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume or quality;
- Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
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 ImplantsDental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use). | Device | Study Group |
Primary outcome
Implant survival and success rates
Time frame: 36 months after implant placement
Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
5 secondary outcomes
Implant survival and success rates
Time frame: 6, 12 and 24 months after implant placement
Prosthetic survival and success rates
Time frame: 12, 24 and 36 months after implant placement
Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire
Time frame: 6, 12, 24 and 36 months after implant placement
Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire
Time frame: Implant placement, 12, 24 and 36 months after implant placement
Rate of adverse events related to the implant, prosthesis, surgery and oral health
Time frame: Implant placement, 6, 12, 24 and 36 months after implant placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Larissa Trojan, PhD study chair
Neodent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw, Edentulous and Jaw, Edentulous, Partially, run by Neodent at 2 sites in Brazil.
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 16 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: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 survival and success rates (time frame: 36 months after implant placement). 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 10 Feb 2023.