Back to resultsBone Level Tapered Multi-Center Study
Primary Purpose
Tooth Loss
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straumann Bone Level Tapered Implant - Immediate Placement
Straumann Bone Level Tapered Implant - Delayed Placement
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring Dental Implants, Single-Tooth
Eligibility Criteria
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
Sites / Locations
- UCLA School of Dentistry
- Center for Implant Dentistry, University of Florida
- University of Texas Health Science Center San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Immediate Placement - Test
Delayed Placement - Control
Arm Description
Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.
Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Outcomes
Primary Outcome Measures
Mean crestal bone level change
Crestal bone levels on both the mesial and distal aspect of the implant will be averaged to calculate the crestal bone level. Mean crestal bone level change from implant loading to 12 months post-implant loading will be measured and compared between test and control arms
Secondary Outcome Measures
Implant success
A dental implant will be considered successful when all of the protocol defined success criteria are met. The percent of successful implants in the test and control arms will be compared at 12 months post-loading.
Implant survival
A dental implant will be considered surviving when it is in place at the time of follow-up. The percent of surviving implants in the test and control arms will be compared at 12 months post-loading.
Buccal bone dimensional changes
Buccal bone dimensional changes will be measured on cone beam computed tomography (CBCT) images. Outcome measurements are currently being defined and will be updated when available.
Change in implant stability
Implant stability measured by resonance frequency analysis (RFA) and reported as an Implant Stability Quotient (ISQ). The mean change in ISQ will be compared between the test and control groups from implant placement to implant loading; and from implant placement to final restoration.
Change in soft tissue - gingival margin
Gingival margin is the length of the crown from highest point of the soft tissue margin to the incisal edge in millimeters on the implant crown and two adjacent crowns. The mean change in gingival margin from baseline (at final restoration) to 12 months post-loading will be compared between the test and control arms.
Change in soft tissue - papilla margin
Papilla margin is the distance from the top of the papilla to the incisal edge mesial and distal of the implant crown. The mean change in papilla margin from baseline (at final restoration) to 12 months post-loading will be compared between the test and control arms.
Subject satisfaction with esthetics
Subject satisfaction with esthetics will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with esthetics will be determined and compared between the two arms at each time point at 12 months post-loading.
Subject satisfaction with function
Subject satisfaction with function will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with function will be determined and compared between the two arms at 12 months post-loading.
Subject satisfaction with the level of pain
Subject satisfaction with the level of pain will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with the level of pain will be determined and compared between the two arms at 12 months post-loading.
Frequency of adverse events and adverse device effects
The frequency of adverse events and adverse device effects will be determined at 12 months post-loading and compared between the test and control arms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02569671
Brief Title
Bone Level Tapered Multi-Center Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Dental Implants, Single-Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Placement - Test
Arm Type
Other
Arm Description
Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.
Arm Title
Delayed Placement - Control
Arm Type
Other
Arm Description
Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Intervention Type
Device
Intervention Name(s)
Straumann Bone Level Tapered Implant - Immediate Placement
Intervention Description
Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
Intervention Type
Device
Intervention Name(s)
Straumann Bone Level Tapered Implant - Delayed Placement
Intervention Description
Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
Primary Outcome Measure Information:
Title
Mean crestal bone level change
Description
Crestal bone levels on both the mesial and distal aspect of the implant will be averaged to calculate the crestal bone level. Mean crestal bone level change from implant loading to 12 months post-implant loading will be measured and compared between test and control arms
Time Frame
Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
Secondary Outcome Measure Information:
Title
Implant success
Description
A dental implant will be considered successful when all of the protocol defined success criteria are met. The percent of successful implants in the test and control arms will be compared at 12 months post-loading.
Time Frame
Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
Title
Implant survival
Description
A dental implant will be considered surviving when it is in place at the time of follow-up. The percent of surviving implants in the test and control arms will be compared at 12 months post-loading.
Time Frame
Measured at 10 days post-surgery, 8 weeks post-surgery, 10-12 weeks post-surgery, 5 weeks post-loading, 8-12 weeks post-loadding, 6 months post-loading, and 12 months post-loading
Title
Buccal bone dimensional changes
Description
Buccal bone dimensional changes will be measured on cone beam computed tomography (CBCT) images. Outcome measurements are currently being defined and will be updated when available.
Time Frame
Measured at screening and 12 months post-loading
Title
Change in implant stability
Description
Implant stability measured by resonance frequency analysis (RFA) and reported as an Implant Stability Quotient (ISQ). The mean change in ISQ will be compared between the test and control groups from implant placement to implant loading; and from implant placement to final restoration.
Time Frame
Measured at implant placement (immediately at tooth extraction or 16-18 weeks after tooth extraction), implant loading (10-12 weeks after implant surgery), and final restoration (8-12 weeks after implant surgery)
Title
Change in soft tissue - gingival margin
Description
Gingival margin is the length of the crown from highest point of the soft tissue margin to the incisal edge in millimeters on the implant crown and two adjacent crowns. The mean change in gingival margin from baseline (at final restoration) to 12 months post-loading will be compared between the test and control arms.
Time Frame
Measured at final restoration (8-12 weeks post loading) and 12 months post-loading. Note that loading is 10-12 weeks after implant surgery.
Title
Change in soft tissue - papilla margin
Description
Papilla margin is the distance from the top of the papilla to the incisal edge mesial and distal of the implant crown. The mean change in papilla margin from baseline (at final restoration) to 12 months post-loading will be compared between the test and control arms.
Time Frame
Measured at final restoration (8-12 weeks post loading) and 12 months post-loading. Note that loading is 10-12 weeks after implant surgery.
Title
Subject satisfaction with esthetics
Description
Subject satisfaction with esthetics will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with esthetics will be determined and compared between the two arms at each time point at 12 months post-loading.
Time Frame
Measured at 12 months post-loading
Title
Subject satisfaction with function
Description
Subject satisfaction with function will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with function will be determined and compared between the two arms at 12 months post-loading.
Time Frame
Measured at 12 months post-loading
Title
Subject satisfaction with the level of pain
Description
Subject satisfaction with the level of pain will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with the level of pain will be determined and compared between the two arms at 12 months post-loading.
Time Frame
Measured at 12 months post-loading
Title
Frequency of adverse events and adverse device effects
Description
The frequency of adverse events and adverse device effects will be determined at 12 months post-loading and compared between the test and control arms.
Time Frame
Measured at 12 months post-loading
Other Pre-specified Outcome Measures:
Title
Mean crestal bone level change over long term
Description
Crestal bone levels on both the mesial and distal aspect of the implant will be averaged to calculate the crestal bone level. Mean crestal bone level change from implant loading to 24, 36, 48 and 60 months post-implant loading will be measured and compared between test and control arms.
Time Frame
Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading
Title
Implant success over long term
Description
A dental implant will be considered successful when all of the protocol defined success criteria are met. The percent of successful implants in the test and control arms will be compared at, 24, 36, 48 and 60 months post-loading.
Time Frame
Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading
Title
Implant survival over long term
Description
A dental implant will be considered surviving when it is in place at the time of follow-up. The percent of surviving implants in the test and control arms will be compared at 24, 36, 48 and 60 months post-loading.
Time Frame
Measured at 24, 36, 48 and 60 months post-loading
Title
Change in soft tissue - gingival margin over long term
Description
Gingival margin is the length of the crown from highest point of the soft tissue margin to the incisal edge in millimeters on the implant crown and two adjacent crowns. The mean change in gingival margin from baseline (at final restoration) to 24, 36, 48 and 60 months post-loading will be compared between the test and control arms.
Time Frame
Measured at final restoration (8-12 weeks after loading) and 24, 36, 48 and 60 months post-loading. Note that loading is at 10-12 weeks after surgery.
Title
Change in soft tissue - papilla margin over long term
Description
Papilla margin is the distance from the top of the papilla to the incisal edge mesial and distal of the implant crown. The mean change in papilla margin from baseline (at final restoration) to 24, 36, 48 and 60 months post-loading will be compared between the test and control arms.
Time Frame
Measured at final restoration (8-12 weeks after loading) and 24, 36, 48 and 60 months post-loading. Note that loading is at 10-12 weeks after surgery.
Title
Subject satisfaction with esthetics over long term
Description
Subject satisfaction with esthetics will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with esthetics will be determined and compared between the two arms at each time point at 24, 36, 48 and 60 months post-loading.
Time Frame
Measured at 24, 36, 48 and 60 months post-loading
Title
Subject satisfaction with function over long term
Description
Subject satisfaction with function will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with function will be determined and compared between the two arms at 24, 36, 48 and 60 months post-loading.
Time Frame
Measured at 24, 36, 48 and 60 months post-loading
Title
Subject satisfaction with the level of pain over long term
Description
Subject satisfaction with the level of pain will be measured on a visual analog scale and reported in millimeters. The subjects will be instructed to mark their level of satisfaction. The mean change in subject satisfaction with the level of pain will be determined and compared between the two arms at 24, 36, 48 and 60 months post-loading.
Time Frame
Measured at 24, 36, 48 and 60 months post-loading
Title
Frequency of adverse events and adverse device effects over long term
Description
The frequency of adverse events and adverse device effects will be determined at 24, 36, 48 and 60 months post-loading and compared between the test and control arms.
Time Frame
Measured at 24, 36, 48 and 60 months post-loading
Title
Buccal bone dimensional changes over long term
Description
Buccal bone dimensional changes will be measured on cone beam computed tomography (CBCT) images. Outcome measurements are currently being defined and will be updated when available.
Time Frame
Measured at screening and 24, 36, 48 and 60 months post-loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L. Cochran, DDS, PhD, MS
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
Center for Implant Dentistry, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0434
Country
United States
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Bone Level Tapered Multi-Center Study
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