An Observational Study of the T3 Pro Dental Implant System (NCT05498662) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Observational Study of the T3 Pro Dental Implant System
United States60 participantsStarted 2022-09-08
Plain-language summary
A prospective, observational, multicenter study where 60 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.
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 at least 18 years of age
. Patients for whom a decision has already been made to use a dental implant in an edentulous or immediately removed tooth site to be fully restored in the mandible or maxilla.
. Site planned for immediate extraction and immediate restoration should have intact bony walls- Type I (as described in Special Procedures section) sockets as verified by CBCT and during surgery; Type II may be considered at the discretion of the treating clinician
. Previously extracted sites (healed at least 3-4 months)
. For all sites, presence of opposing dentition (antagonist may be natural teeth or implant supported prosthesis) that will allow for functional occlusion is essential.
. The site intended for implant placement should have at least 10mm of alveolar bone height and sufficient restorative space for a restoration; without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips and/or allograft (i.e.: Puros) to improve soft tissue attachment.
. Patients must be physically able to tolerate conventional surgical and restorative procedures (IV sedation protocols may be used at the discretion of the treating clinician).
. Patients who provide a signed informed consent.
Exclusion criteria
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.
What they're measuring
1
Integration success/ implant survival at 2 years; primary stability
. Patients with known systemic diseases such as diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders that are uncontrolled at the time of enrollment.
. Patients with current use of bisphosphonates.
. Patients with active infection or severe inflammation in the areas intended for treatment.
. Patients with more than10 cigarette per day smoking habit.
. Patients with a history of therapeutic radiation to the head or jaw.
. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
. Patients with evidence of untreated severe parafunctional habits such as bruxing or clenching.
. Patients who have previously failed dental implants at the site intended for study implant placement