Straumann Roxolid Multi-Center Study
Primary Purpose
Jaw, Edentulous, Partially
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straumann Bone Level Implants, 4.1 mm implant diameter
Straumann Bone Level Implants, 3.3 mm implant diameter
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Implant
Eligibility Criteria
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
Sites / Locations
- UCLA School of Dentistry
- Boston University, School of Dental Medicine
- New York University College of Dentistry
- Univeristy of Texas Health Science Center San Antonio
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
4.1 mm implant diameter
3.3 mm implant diameter
Arm Description
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Outcomes
Primary Outcome Measures
Mean Crestal Bone Level Change
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.
Secondary Outcome Measures
Additional Mean Crestal Bone Level Changes
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
Implant Success Rate
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)
Implant Survival Rate
Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
Gingival Recession
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.
Number of Participants With Adverse Events and Adverse Device Effects
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").
Subject Satisfaction
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01842958
Brief Title
Straumann Roxolid Multi-Center Study
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery and 12 months post-implant placement. The secondary objectives will assess differences in clinical outcomes between the test and control implants, including implant success and survival, gingival recession, subject satisfaction and additional early bone level measurements.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Dental Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4.1 mm implant diameter
Arm Type
Active Comparator
Arm Description
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Arm Title
3.3 mm implant diameter
Arm Type
Experimental
Arm Description
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Intervention Type
Device
Intervention Name(s)
Straumann Bone Level Implants, 4.1 mm implant diameter
Intervention Description
Straumann Bone Level Implants, 4.1 mm implant diameter
Intervention Type
Device
Intervention Name(s)
Straumann Bone Level Implants, 3.3 mm implant diameter
Intervention Description
Straumann Bone Level Implants, 3.3 mm implant diameter
Primary Outcome Measure Information:
Title
Mean Crestal Bone Level Change
Description
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.
Time Frame
Baseline (implant placement) and 12 months post loading
Secondary Outcome Measure Information:
Title
Additional Mean Crestal Bone Level Changes
Description
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
Time Frame
Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
Title
Implant Success Rate
Description
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)
Time Frame
25 days, 6 months post loading, and 12 months post loading
Title
Implant Survival Rate
Description
Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
Time Frame
7 days, 25 days, 6 months post loading, and 12 months post loading
Title
Gingival Recession
Description
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.
Time Frame
6 months to 12 months post loading
Title
Number of Participants With Adverse Events and Adverse Device Effects
Description
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").
Time Frame
Duration of the study from surgical visit to the 12 months post-loading visit
Title
Subject Satisfaction
Description
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)
Time Frame
12 months post loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L. Cochran, DDS, MS, PhD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA School of Dentistry
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1668
Country
United States
Facility Name
Boston University, School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
New York University College of Dentistry
City
New York
State/Province
New York
ZIP/Postal Code
10019-5404
Country
United States
Facility Name
Univeristy of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7444
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Straumann Roxolid Multi-Center Study
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