Edentulous Alveolar RidgeNCT05260892
Incisors Single-Unit Rehabilitation With Narrow GM Implants
An observational study of Edentulous Alveolar Ridge, run by Neodent at 2 sites in Brazil.
Trial summary
The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Narrow GM implants
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2022to 15 Dec 2025
- 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 presenting 18 years of age or more, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses. Patients that give written informed consent to participate in this clinical study.
Who may be able to join
- Patients with 18 years of age or more
- At least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible
- Presence of natural adjacent and opposing tooth,
- Qualified for rehabilitation with narrow implants and single-unit fixed prostheses.
Who cannot join
- As exclusion criteria, the contraindications, and warnings according to the Instructions for Use of the device will be applied, as follows:
- Signs of allergy or hypersensitivity to titanium
- Periodontal disease
- heavy smoking/alcohol drinking habits
- bruxism
- high use of bisphosphonate drugs or proton pump inhibitors (PPIs)
Show all 15Show fewer
- radiation therapy
- diabetes
- autoimmune diseases
- uncontrolled systemic complications or diseases
- incomplete jawbone growth
- bleeding disorders
- HIV
- osteoporosis
- pregnancy.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Escola de Aperfeiçoamento Profissional dos Cirurgiões Dentistas de Goiás, EAPGOIAS.
Goiânia, Goiás, 74070-070
Eduardo Zancopé, MSc, +55 62 3212-4545, ezancope@gmail.com
Eduardo Zancopé, MSc
- Recruiting
Universidade Federal de Uberlândia, Faculdade de Odontologia, Área de Oclusão Prótese Fixa e Materiais Odontológicos.
Uberlândia, Minas Gerais, 38408-100
Flávio D das Neves, PhD, 55 34 3225-8105, flaviodominguesneves@gmail.com
Flávio D Neves, PhD
About this study
Official title: Incisors Single-Unit Rehabilitation With Narrow GM Implants: Observational Prospective Study
The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational study using these devices.
Read more
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).
55 patients (needed to obtain a sample size of 55 implants) 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.
The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational 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 Instruction for Use (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.
The sample will be prospectively selected and will consist of 55 patients, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, presenting natural adjacent and opposing tooth, and who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses. Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure.
GM Narrow implants will be placed under local anesthesia by guided or conventional surgery - as chosen by the surgeon - and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants can be placed in the same patient, as indicated. Implants must be installed 2mm infra-bony.
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); TP - Implants placement; T0 - Implant Loading; TF - final prosthesis T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant loading.
Panoramic radiographs, periapical radiographs, and computed tomography (CT) scans will be obtained from the region of interest before surgery, for surgical planning. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (TP - immediately or within 1 week after implant placement) and during the post-operative stages (T0, TF, T6, T12, T24, and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
Moreover, soft tissue evaluation will be conducted at the pre-treatment (Screening visit), for the regions to be rehabilitated with the study implants and in the postoperative period, at T0, TF, T6, T12, T24, and T36, for all study implants.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Narrow GM implants
- Keywords
- dental implants, oral rehabilitation, extra narrow implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow GM implantsDevice
Rehabilitation of superior lateral incisors or inferior central and lateral incisors with narrow implants supporting single unit or partial prostheses
| Study group | Role | What they receive |
|---|---|---|
| Narrow GM | Patients presenting at least onde edentulous site rehabilitated with Narrow GM implant Receives: Device: Narrow GM implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant bone level change
Amount of peri-implant bone level change
Measured: up to 36 months
Secondary outcomes (7)
Periimplant bone level
The peri-implant bone level will be measured on the periapical radiographs obtained as the distance between the coronal margin of the implant shoulder and the most coronal point of the peri-implant bone, on the mesial and distal surfaces of each implant. The horizontal measurement of the remodeling will be done, when there is no bone contact in the cervical part of the implant. This measurement will be performed from the superior site of the bone crest to the lateral edge of the implant, perpendicular to the long axis of the implant.
Measured: up to 36 months
Implant Survival
Implant survival will be defined as the absence of implant loss at each follow-up.
Measured: up to 36 months
Implant success
The implant success will be assessed according to:
- Absence of persisting subjective discomfort such as pain, foreign body perception, and or dysaesthesia (painful sensation);
- Absence of recurrent peri-implant infection with suppuration (infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics);
- Absence of implant mobility on manual palpation;
- Absence of any continuous peri-implant radiolucency.
Measured: up to 36 months
Prosthetic Survival
Prosthetic survival will be assessed as the final prosthesis remaining in situ at each follow-up, irrespective of its condition.
Measured: up to 36 months
Prosthetic Success
Success will be defined as the prosthesis that remained unchanged and did not require any intervention, except routine occlusal adjustments, during the entire observational period.
Measured: up to 36 months
Patient Satisfaction with treatment: questionnaire
Portuguese translation of the OHIP-14 [20,21] (Annex III) questionnaire will be used to assess Oral Health-Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Patients will be asked how frequently they have been experiencing the problems assessed by the questionnaire.
Measured: up to 36 months
Clinician Satisfaction with treatment: 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 evaluate his/her satisfaction with the surgical procedure, experience with the use of the abutments, as well as with the surgical and prosthetic results obtained.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Oct 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Waleska C Furquim, PhD, Study director, Neodent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260892
- Sponsor's protocol ID
- CS.O.004
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2022
- 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
- Incisors Single-Unit Rehabilitation With Narrow GM Implants: Observational Prospective Study
- ClinicalTrials.gov ID
- NCT05260892
- Acronym / sponsor ID
- CS.O.004
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- dental implants, oral rehabilitation, extra narrow implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational study using 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).
55 patients (needed to obtain a sample size of 55 implants) 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.
The Narrow GM Implants were designed for oral functional rehabilitation using dental implants, allowing for treatment of patients with different bone qualities in the region of lateral incisors in the maxilla or the region of lateral and central incisors in the mandible.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of the Narrow GM System in a daily dental practice setting, by means of a prospective collection of clinical data in an observational 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 Instruction for Use (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.
The sample will be prospectively selected and will consist of 55 patients, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, presenting natural adjacent and opposing tooth, and who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses. Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure.
GM Narrow implants will be placed under local anesthesia by guided or conventional surgery - as chosen by the surgeon - and with adequate bone bed preparation, as recommended by the manufacturer. Multiple implants can be placed in the same patient, as indicated. Implants must be installed 2mm infra-bony.
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); TP - Implants placement; T0 - Implant Loading; TF - final prosthesis T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant loading.
Panoramic radiographs, periapical radiographs, and computed tomography (CT) scans will be obtained from the region of interest before surgery, for surgical planning. Additionally, standardized digital periapical radiographs will be taken in a usual daily practice frequency, as determined by the investigator: after implants placement (TP - immediately or within 1 week after implant placement) and during the post-operative stages (T0, TF, T6, T12, T24, and T36) to assess the osseointegration process, changes in peri-implant bone level as well as prosthetic settlement and integrity.
Moreover, soft tissue evaluation will be conducted at the pre-treatment (Screening visit), for the regions to be rehabilitated with the study implants and in the postoperative period, at T0, TF, T6, T12, T24, and T36, for all study implants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrow GM | – | Device: Narrow GM implantsPatients presenting at least onde edentulous site rehabilitated with Narrow GM implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting 18 years of age or more, with at least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible, who are qualified for rehabilitation with narrow implants and single-unit fixed prostheses. Patients that give written informed consent to participate in this clinical study.
Key inclusion criteria (4 listed)
- Patients with 18 years of age or more
- At least one edentulous site in the region of lateral incisors in the maxilla and/or lateral and central incisors in the mandible
- Presence of natural adjacent and opposing tooth,
- Qualified for rehabilitation with narrow implants and single-unit fixed prostheses.
Key exclusion criteria (15 listed)
- As exclusion criteria, the contraindications, and warnings according to the Instructions for Use of the device will be applied, as follows:
- Signs of allergy or hypersensitivity to titanium
- Periodontal disease
- heavy smoking/alcohol drinking habits
- bruxism
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 |
|---|---|---|
| Narrow GM implantsRehabilitation of superior lateral incisors or inferior central and lateral incisors with narrow implants supporting single unit or partial prostheses | Device | Narrow GM |
Primary outcome
Peri-implant bone level change
Time frame: up to 36 months
Amount of peri-implant bone level change
7 secondary outcomes
Periimplant bone level
Time frame: up to 36 months
Implant Survival
Time frame: up to 36 months
Implant success
Time frame: up to 36 months
Prosthetic Survival
Time frame: up to 36 months
Prosthetic Success
Time frame: up to 36 months
Patient Satisfaction with treatment: questionnaire
Time frame: up to 36 months
Clinician Satisfaction with treatment: questionnaire
Time frame: up to 36 months
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.
Waleska C Furquim, PhD study director
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 Edentulous Alveolar Ridge, 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 4 inclusion and 15 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta S Rocha, MSc (+55 41 2169-4000 ext. 4821, roberta.rocha@neodent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant bone level change (time frame: up to 36 months). 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.