Bone Level Tapered Multi-Center Study



Status:Active, not recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:7/11/2018
Start Date:March 2016
End Date:March 2024

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Immediate Placement of the Straumann® Bone Level Tapered Implant With Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed Placement

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).

The primary objective is to demonstrate that the change in mean peri-implant marginal bone
level changes (mesial and distal) from loading to 12 months post-loading of the test
treatment will not be worse than the control treatments.

The secondary objectives of the study are to assess differences in clinical and radiographic
outcomes between the test and control treatments at 12 months post-loading by looking at
implant success and survival, buccal bone dimensional changes, implant stability, soft tissue
changes, subject satisfaction, and adverse events.

An additional objective is to assess long-term differences in clinical and radiographic
outcomes, as measured in the primary and secondary objectives, over the span of two, three,
four, and five years.

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 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
We found this trial at
3
sites
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Gainesville, Florida 32610
Phone: 352-273-6669
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Los Angeles, California 90095
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Los Angeles, CA
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