Jaw, EdentulousNCT04328116
Study of Neodent Implantable Devices of GM Zygomatic Line
An observational study of Jaw, Edentulous, run by Neodent at 1 site in Brazil.
Trial summary
GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated). 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
- What is being tested?
- Dental Implants
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2020to Mar 2024
- 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: The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants).
Who may be able to join
- 18 years of age or more;
- Opposing dentition (natural teeth or teeth/implant-supported fixed restorations).
Who cannot join
- Symptomatology related to the facial sinuses (maxillary sinusitis, polyps or any other sinus pathologies);
- Unfavorable maxillary relations;
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume and/or quality;
- Systemic complications or diseases such as bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, incomplete jawbone growth, uncooperative and not motivated patient, 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, endocrine diseases, insufficient oral hygiene, and pregnancy.
- Additionally, subjects will be excluded if they present systemic complications that may expose them to an eventual surgical risk if submitted to surgery under general anesthesia or under local anesthesia and sedation (decompensated diabetics, immunosuppressed, patients who were submitted to radiotherapy and chemotherapy less than 4 years or who had a heart attack less than 1 year previously, patients with clinical signs and/or symptoms of sinusitis and congestion and/or nasal secretion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Latino Americano de Pesquisa e Ensino Odontológico
Curitiba, Paraná, 80710-150
About this study
Official title: Prospective Case Series Study of Neodent Implantable Devices of GM Zygomatic Line
GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated).
The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the 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 instructions for use (IFU). Ten patients will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.
Read the detailed description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.
GM Zygomatic implants present an optimized design with adapted treatment protocol, allowing for treatment of patients with severely resorbed maxilla and complete edentulism in which conventional implants placement is contraindicated.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of GM Zygomatic System in a daily dental practice setting, by means of a prospective collection of clinical data in a study using 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 Instructions for Use with the intent to verify that the intended purpose is adequate for all Neodent products involved in the procedure that come into contact with the patient.
The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants). Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure.
Neodent GM Zygomatic implants will preferably be placed under local anesthesia and sedation (according to the surgeon's assessment of the patient's general health), with adequate bone bed preparation, as recommended by the manufacturer. Size, position, and quantity of implants (2 to 4) will be select considering the anatomy, region of rehabilitation, bone quality and quantity and available space. Together with the Zygomatic Implants, 2 to 4 conventional implants of Neodent GM line shall be inserted in the anterior region, if enough bone is available.
Data concerning the studied variables will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implants placement; TF - final prosthesis (may coincide with TL); TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement.
Computed tomography (CT) scans with prototyping will be obtained from the region of interest prior to surgery, for the surgical planning and implant selection, as well as post-surgery (T0 - immediately or within 1 week after implant placement; T36) to verify zygomatic implants anchorage. Prototypes of the region of interest in the maxilla will be obtained from the initial CT scans for diagnostic purposes. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (T0) and during the post-operative stages (TL, TF, T6, T12, T24, and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
- Conditions
- Jaw, Edentulous
- Being tested
- Dental Implants
- Keywords
- Dental Implants, Zygomatic Implants
- Medical subject headings
- Jaw, Edentulous
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 GM Zygomatic 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 rate
Implant survival will be defined as no loss of the implant at each follow-up.
Measured: 36 months after implant placement.
Implant success rate
Evaluation of implant success will be assessed based on the criteria by Byser et al (1990).
Measured: 36 months after implant placement.
Secondary outcomes (10)
Implant survival rate
Implant survival will be defined as no loss of the implant at each follow-up.
Measured: 6, 12, and 24 months after implant placement.
Implant success rate
Evaluation of implant success will be assessed based on the criteria by Byser et al (1990).
Measured: 6, 12, and 24 months after implant placement.
Prosthetic survival rate
Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition.
Measured: 12, 24, and 36 months after implant placement.
Prosthetic success rate
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
The portuguese translation of OHIP-14 [12,13] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment.
Measured: Before implant placement and 6, 12, 24, and 36 months after implant placement.
Clinician Satisfaction
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.
Measured: Immediately after implant placement, 12, 24, and 36 months after implant placement.
Adverse events related to the implant.
Determined by inquiring with the patient and clinical evaluation.
Measured: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Adverse events related to the prosthesis.
Determined by inquiring with the patient and clinical evaluation.
Measured: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Adverse events related to the surgery.
Determined by inquiring with the patient and clinical evaluation.
Measured: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Adverse events related to the oral health
Determined by inquiring with the patient and clinical evaluation.
Measured: Immediately after 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 posted31 Mar 2020
- Study start15 Jul 2020
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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
- 16 participants (actual)
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
- NCT04328116
- Sponsor's protocol ID
- CS.O.008
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2020
- Last updated
- 9 Nov 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Series Study of Neodent Implantable Devices of GM Zygomatic Line
- ClinicalTrials.gov ID
- NCT04328116
- Acronym / sponsor ID
- CS.O.008
- Conditions
- Jaw, Edentulous
- Keywords
- Dental Implants, Zygomatic Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 31 Mar 2020 (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.
GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated).
The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the 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 instructions for use (IFU). Ten patients will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.
Detailed description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.
GM Zygomatic implants present an optimized design with adapted treatment protocol, allowing for treatment of patients with severely resorbed maxilla and complete edentulism in which conventional implants placement is contraindicated.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of GM Zygomatic System in a daily dental practice setting, by means of a prospective collection of clinical data in a study using 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 Instructions for Use with the intent to verify that the intended purpose is adequate for all Neodent products involved in the procedure that come into contact with the patient.
The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants). Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure.
Neodent GM Zygomatic implants will preferably be placed under local anesthesia and sedation (according to the surgeon's assessment of the patient's general health), with adequate bone bed preparation, as recommended by the manufacturer. Size, position, and quantity of implants (2 to 4) will be select considering the anatomy, region of rehabilitation, bone quality and quantity and available space. Together with the Zygomatic Implants, 2 to 4 conventional implants of Neodent GM line shall be inserted in the anterior region, if enough bone is available.
Data concerning the studied variables will be collected following the procedures and assessments plan by fulfilling the Case Report Form (CRF), in the following stages: First visit (Screening); T0 - Implants placement; TF - final prosthesis (may coincide with TL); TL - Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant placement.
Computed tomography (CT) scans with prototyping will be obtained from the region of interest prior to surgery, for the surgical planning and implant selection, as well as post-surgery (T0 - immediately or within 1 week after implant placement; T36) to verify zygomatic implants anchorage. Prototypes of the region of interest in the maxilla will be obtained from the initial CT scans for diagnostic purposes. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (T0) and during the post-operative stages (TL, TF, T6, T12, T24, and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Dental ImplantsNeodent GM Zygomatic 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
- The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants).
Key inclusion criteria (2 listed)
- 18 years of age or more;
- Opposing dentition (natural teeth or teeth/implant-supported fixed restorations).
Key exclusion criteria (7 listed)
- Symptomatology related to the facial sinuses (maxillary sinusitis, polyps or any other sinus pathologies);
- Unfavorable maxillary relations;
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume and/or quality;
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 rate
Time frame: 36 months after implant placement.
Implant survival will be defined as no loss of the implant at each follow-up.
Implant success rate
Time frame: 36 months after implant placement.
Evaluation of implant success will be assessed based on the criteria by Byser et al (1990).
10 secondary outcomes
Implant survival rate
Time frame: 6, 12, and 24 months after implant placement.
Implant success rate
Time frame: 6, 12, and 24 months after implant placement.
Prosthetic survival rate
Time frame: 12, 24, and 36 months after implant placement.
Prosthetic success rate
Time frame: 12, 24, and 36 months after implant placement.
Patient Satisfaction
Time frame: Before implant placement and 6, 12, 24, and 36 months after implant placement.
Clinician Satisfaction
Time frame: Immediately after implant placement, 12, 24, and 36 months after implant placement.
Adverse events related to the implant.
Time frame: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Adverse events related to the prosthesis.
Time frame: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Adverse events related to the surgery.
Time frame: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Adverse events related to the oral health
Time frame: Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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
1 site 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, run by Neodent at 1 site 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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 rate (time frame: 36 months after implant placement.). The study lists 2 primary outcomes in all. 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 9 Nov 2023.