Bone Level Tapered Multi-Center Study

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Device: Straumann Bone Level Tapered Implant - Immediate Placement; Device: Straumann Bone Level Tapered Implant - Delayed Placement

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1668
      • UCLA School of Dentistry
  • Florida
    • Gainesville, Florida, United States, 32610-0434
      • Center for Implant Dentistry, University of Florida
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured at implant loading (10-12 weeks after implant surgery) and 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.	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
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.	Measured at screening and 12 months post-loading
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.	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)
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.	Measured at final restoration (8-12 weeks post loading) and 12 months post-loading. Note that loading is 10-12 weeks after implant surgery.
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.	Measured at final restoration (8-12 weeks post loading) and 12 months post-loading. Note that loading is 10-12 weeks after implant surgery.
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.	Measured 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.	Measured 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.	Measured 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.	Measured at 12 months post-loading

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean crestal bone level change over long term	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.	Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading
Implant success over long term	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.	Measured at implant loading (10-12 weeks after implant surgery), 24, 36, 48 and 60 months post-loading
Implant survival over long term	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.	Measured at 24, 36, 48 and 60 months post-loading
Change in soft tissue - gingival margin over long term	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.	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.
Change in soft tissue - papilla margin over long term	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.	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.
Subject satisfaction with esthetics over long term	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.	Measured at 24, 36, 48 and 60 months post-loading
Subject satisfaction with function over long term	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.	Measured at 24, 36, 48 and 60 months post-loading
Subject satisfaction with the level of pain over long term	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.	Measured at 24, 36, 48 and 60 months post-loading
Frequency of adverse events and adverse device effects over long term	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.	Measured at 24, 36, 48 and 60 months post-loading
Buccal bone dimensional changes over long term	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.	Measured at screening and 24, 36, 48 and 60 months post-loading

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: David L. Cochran, DDS, PhD, MS, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 12, 2019
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dental Implants, Single-Tooth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: CR 01/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No