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 range18 Years
SexALL
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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…
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