Incisors Single-Unit Rehabilitation With Narrow GM Implants
Brazil55 participantsStarted 2022-10-01
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
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)
* radiation therapy
* diabetes
* autoimmune diseases
* uncontrolled systemic complications or diseases
* incomplete jawbone growth
* bleeding disorders
* HIV
* osteoporosis
* pregnancy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.