Titanium Zirconium (TiZr) Mini Implants (NCT03837158) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Titanium Zirconium (TiZr) Mini Implants
Switzerland72 participantsStarted 2019-09-01
Plain-language summary
H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.
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:
* At patient level:
* Written informed consent
* Age ≥ 18 years
* Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year
* Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment
* At site level:
* Healed edentulous mandible (minimum 8 weeks since last extraction)
* Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants
* Opposing dentition: complete denture on a edentulous maxilla
* Physical status (PS) 1 and 2 (American Society of Anesthesiologists)
Exclusion Criteria:
* At patient level
* Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
* Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
* Pregnancy or lactation
* Heavy smoking habit with \> 20 cig/d
* Severe bruxism or clenching habits, present oro-facial pain
* At site level:
* Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the…
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.