Bone Level Tapered Multi-Center Study (NCT02569671) | Clinical Trial Compass
CompletedNot Applicable
Bone Level Tapered Multi-Center Study
United States53 participantsStarted 2016-03
Plain-language summary
The aim of this randomized, controlled, multi-center study is to assess the clinical and radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites (control).
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:
* Subjects must have voluntarily signed the informed consent form before any study related procedures
* Subjects must be males or females who are a minimum of 18 years of age
* Subjects who are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and replacement with a dental implant.
* Implants must be placed either immediately in an extraction socket or placed in a healed site (greater than 4 months healing) which has not been previously grafted.
* Planned site for implant must have a natural tooth both mesially and distally in the adjacent tooth positions
* Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
* There must be sufficient bone at the implant site to achieve primary stability
* Subjects must be committed to the study and the required follow-up visits
* Subjects must be in good general health as assessed by the Investigator
Exclusion Criteria:
* Subjects with a systemic disease that would preclude dental implant surgery
* Subjects with any contraindications for oral surgical procedures
* Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
* Subjects with a history of local irradiation therapy in the head/neck area
* Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
* Subjects receiving, or having a histor…
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
Mean Crestal Bone Level Change
Timeframe: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading