- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01842958
Straumann Roxolid Multi-Center Study
A Randomized, Controlled, Multi-center Clinical Study Evaluating the Crestal Bone Level Changes of Straumann BL Ø 3.3 mm NC SLActive RXD Implants Compared to Straumann BL Ø 4.1 mm RC SLActive RXD Implants for Single Tooth Replacement.
Study Overview
Status
Conditions
Detailed Description
This is a randomized, controlled, multi-center clinical study. The total study duration for each patient should be 12 ± 1 months.
Straumann Bone Level implants will be placed in the pre-molar or anterior region of the mandible or maxilla for single tooth replacement, followed by provisional prosthetic loading after 25 ± 4 days and by final prosthetic loading 6 ± 1 months after implant loading.
In total 6 visits per patient are scheduled in this study. Bone level changes, implant success and survival, gingival recession, subject satisfaction and adverse events (AEs) will be assessed.
The study devices are CE-(Conformité Européenne, meaning European Conformity) marked products. Straumann Bone Level implants Ø 3.3 mm NC SLActive Roxolid and Straumann Bone Level Ø 4.1 mm RC SLActive implants.
Five centers in USA will participate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-1668
- UCLA School of Dentistry
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston University, School of Dental Medicine
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New York
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New York, New York, United States, 10019-5404
- New York University College of Dentistry
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Texas
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San Antonio, Texas, United States, 78229
- Univeristy of Texas Health Science Center San Antonio
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Washington
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Seattle, Washington, United States, 98195-7444
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must have voluntarily signed the informed consent form
- Subjects must be males or females who are a minimum of 20 years of age
- Subjects must have a single tooth gap in the pre-molar or anterior region of the mandible or maxilla (ADA tooth positions 4-13 and 20-29; FDI tooth positions 11-15, 21-25, 31-35, and 41-45)
- Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
- Subjects must have a full mouth plaque score ≤ 25%, according to O'Leary, at the time of screening
- Subjects must have adequate bone to encapsulate the implant and allow placement of an Ø 4.1 mm Bone Level Implant.
- Adequate bone height of at least 1 mm longer than the length of the study implant
- Subjects must have substantially healed (at least 16 weeks after tooth extraction) extraction sockets
- 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 (e.g. serious internal medical problems, disorders of bone metabolism, uncontrolled bleeding disorders, weakened immune system, illness requiring periodic use of steroids, uncontrollable endocrine disorders, uncontrolled diabetes)
- Subjects with any contraindications for oral surgical procedures (e.g. inadequate wound healing capacity, poor oral hygiene, maxillary and mandibular growth not completed, xerostomia)
- 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
- Subjects with existing implants in the adjacent positions to the planned implant site
- Subjects requiring bone augmentation or socket grafting within 6 months prior to surgery
- Subjects requiring more than minimal simultaneous augmentation for minimal buccal dehiscence defects (defect cannot be greater than 3mm in height)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 4.1 mm implant diameter
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
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Straumann Bone Level Implants, 4.1 mm implant diameter
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EXPERIMENTAL: 3.3 mm implant diameter
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
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Straumann Bone Level Implants, 3.3 mm implant diameter
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Crestal Bone Level Change
Time Frame: Baseline (implant placement) and 12 months post loading
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Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.
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Baseline (implant placement) and 12 months post loading
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional Mean Crestal Bone Level Changes
Time Frame: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
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Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading
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Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
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Implant Success Rate
Time Frame: 25 days, 6 months post loading, and 12 months post loading
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Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant)
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25 days, 6 months post loading, and 12 months post loading
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Implant Survival Rate
Time Frame: 7 days, 25 days, 6 months post loading, and 12 months post loading
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Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
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7 days, 25 days, 6 months post loading, and 12 months post loading
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Gingival Recession
Time Frame: 6 months to 12 months post loading
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Soft tissue measurements include: CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters. |
6 months to 12 months post loading
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Number of Participants With Adverse Events and Adverse Device Effects
Time Frame: Duration of the study from surgical visit to the 12 months post-loading visit
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Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading.
The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes "possibly related", "probably related" and "related").
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Duration of the study from surgical visit to the 12 months post-loading visit
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Subject Satisfaction
Time Frame: 12 months post loading
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Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain. General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain) |
12 months post loading
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David L. Cochran, DDS, MS, PhD, University of Texas Health Science Center San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR 10/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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