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Bone Level Tapered Multi-Center Study

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ClinicalTrials.gov Identifier: NCT02569671
Recruitment Status : Active, not recruiting
First Posted : October 7, 2015
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

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).

Condition or disease Intervention/treatment Phase
Tooth Loss Device: Straumann Bone Level Tapered Implant - Immediate Placement Device: Straumann Bone Level Tapered Implant - Delayed Placement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2024

Arm Intervention/treatment
Immediate Placement - Test
Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth.
Device: Straumann Bone Level Tapered Implant - Immediate Placement
Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Delayed Placement - Control
Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth.
Device: Straumann Bone Level Tapered Implant - Delayed Placement
Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.




Primary Outcome Measures :
  1. Mean crestal bone level change [ Time Frame: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading ]
    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 :
  1. Implant success [ Time Frame: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading ]
    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.

  2. Implant survival [ 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 ]
    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.

  3. Buccal bone dimensional changes [ Time Frame: Measured at screening and 12 months post-loading ]
    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.

  4. Change in implant stability [ 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) ]
    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.

  5. Change in soft tissue - gingival margin [ 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. ]
    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.

  6. Change in soft tissue - papilla margin [ 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. ]
    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.

  7. Subject satisfaction with esthetics [ Time Frame: Measured at 12 months post-loading ]
    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.

  8. Subject satisfaction with function [ Time Frame: Measured at 12 months post-loading ]
    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.

  9. Subject satisfaction with the level of pain [ Time Frame: Measured at 12 months post-loading ]
    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.

  10. Frequency of adverse events and adverse device effects [ Time Frame: Measured at 12 months post-loading ]
    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.


Other Outcome Measures:
  1. Mean crestal bone level change over long term [ Time Frame: Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading ]
    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.

  2. Implant success over long term [ Time Frame: Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading ]
    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.

  3. Implant survival over long term [ Time Frame: Measured at 24, 36, 48 and 60 months post-loading ]
    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.

  4. Change in soft tissue - gingival margin over long term [ 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. ]
    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.

  5. Change in soft tissue - papilla margin over long term [ 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. ]
    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.

  6. Subject satisfaction with esthetics over long term [ Time Frame: Measured at 24, 36, 48 and 60 months post-loading ]
    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.

  7. Subject satisfaction with function over long term [ Time Frame: Measured at 24, 36, 48 and 60 months post-loading ]
    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.

  8. Subject satisfaction with the level of pain over long term [ Time Frame: Measured at 24, 36, 48 and 60 months post-loading ]
    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.

  9. Frequency of adverse events and adverse device effects over long term [ Time Frame: Measured at 24, 36, 48 and 60 months post-loading ]
    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.

  10. Buccal bone dimensional changes over long term [ Time Frame: Measured at screening and 24, 36, 48 and 60 months post-loading ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569671


Locations
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United States, California
UCLA School of Dentistry
Los Angeles, California, United States, 90095-1668
United States, Florida
Center for Implant Dentistry, University of Florida
Gainesville, Florida, United States, 32610-0434
United States, Texas
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Institut Straumann AG
Investigators
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Principal Investigator: David L. Cochran, DDS, PhD, MS University of Texas Health Science Center San Antonio

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Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT02569671     History of Changes
Other Study ID Numbers: CR 01/14
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Institut Straumann AG:
Dental Implants, Single-Tooth

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases