Bone Level Tapered Multi-Center Study

Completed · Not applicable

Conditions studied: Tooth Loss

In brief

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).

Key facts

Study ID

NCT02569671

Run by

Institut Straumann AG

People needed

53

Starts

2016-03-01

Expected to finish

2025-12-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
• Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction
• Any implant sites where there will be a buccal dehiscence greater than 3 mm or there will be a fenestration of the implant
• Subjects with inadequate oral hygiene or who are unmotivated for adequate home care
• Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
• Subjects who are pregnant or intending to become pregnant during the duration of the study
• Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco
• Subjects who abuse alcohol or drugs
• Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
• Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability

Where it is running

• UCLA School of Dentistry — Los Angeles, California, United States
• Center for Implant Dentistry, University of Florida — Gainesville, Florida, United States
• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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