Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national… (NCT03908177) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.
Germany, Hong Kong, Portugal121 participantsStarted 2019-09-07
Plain-language summary
A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
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 must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analysed, and published.
* Patients must be males or females who are a minimum of 18 years of age.
* Patients, who are in need of a single tooth replacement with a dental implant in the premolar-to-premolar area in the mandible or maxilla (excluding lower incisors).
* Presence of natural teeth on both sides of the study implant position and opposing dentition (single tooth gap).
* Patients with healed extraction sockets, which means that at implant surgery:
* Soft tissue coverage of the socket is complete; and
* Alveolar bone is reconsolidated (around 16 weeks after tooth extraction).
Exclusion Criteria:
* Patients with inadequate bone volume where major bone augmentation would be required at implant location.
* Inadequate anatomic situation that would prevent prosthetic-driven planning based on CBCT.
* Presence of implants neighbouring the study implant.
* Patients with inadequate oral hygiene (FMPS ≥ 20%).
* Patients with local root remnants.
* Patients with inadequate wound healing capacity.
* Patients with incomplete maxillary and mandibular growth.
* Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, we…
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
Bone Level Change
Timeframe: 12 months after implant loading (final crown restoration)