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: Completed
• 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

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	mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level	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 and Survival	Control group N-25 Test group N=24 Survival and success was assessed by the dimensions below as noted by Buser.; 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	12 months post-loading
Buccal Bone Dimensional Changes	Buccal bone dimensional changes were measured on images recorded on cone beam computed tomography (CBCT). The average of the following measurement locations is reported as outcome variable: 1) mesial to distal; 2) distal-buccal; 3) mid-buccal; 4) mesial-buccal; 5) distal-lingual; 6) mid-lingual; 7) mesial-lingual.	Measured at Implant loading and at screening and 12 months post-loading
Implant Measure as Measured by ISQ at Implant Surgery	Implant stability as measured by ISQ held facial-lingual and held mesial-lingual. An Osstell device that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration was used in the study. The results were presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements were taken from two different angles at implant placement, implant loading, and final restoration.	Implant surgery: Immediate Placement for Test Group = implant is placed at the time of tooth extraction. Delayed Placement is Control Group= implant is placed after 16-18 weeks of healing
Implant Stability as Measured by ISQ at Implant Loading	Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual. An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements will be taken from two different angles at implant placement, implant loading, and final restoration.	Implant Loading=implant surgery + 10 weeks (+/-3 weeks)
Implant Stability as Measured by ISQ at Final Restoration	Implant stability was measured by ISQ and probe held facial-lingual and held mesial-lingual. An Osstell device is an instrument that uses the Resonance Frequency Analysis (RFA) method to determine implant stability and osseointegration. The result is presented as an Implant Stability Quotient (ISQ) value of 1 - 100. The higher the ISQ, the more stable the implant. Additional information about the Osstell device can be found at www.osstell.com. Instructions on taking the measurements for this protocol will be provided in the Operation Manual. Two measurements will be taken from two different angles at implant placement, implant loading, and final restoration.	Final Restoration: 10 weeks post-loading (± 2 weeks)
Change in Soft Tissue Measurements	The following table illustrates a comparison between Soft Tissue Mean Changes Around the Implant for delayed and immediate placements, measured at final restoration (10 weeks post loading) and the 12-month mark post implant loading. The parameters assessed included: CLTm (length of crown from highest point of soft tissue to incisal edge of the adjacent mesial tooth), CLTd (length of crown from highest point of soft tissue to incisal edge of the adjacent distal tooth), 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)	Soft tissue measurements were taken and compared between the test and the control group at final restoration (10 weeks post loading) and 12 months (± 1 month) post implant loading (implant loading=implant surgery + 10 weeks (+/-3 weeks)).
Subject Satisfaction	Subject satisfaction related to pain, crown's esthetic, and crown's function was assessed at 12 months post-loading using Visual Analog Scales (VAS). Satisfaction range between 0 to 100 with Excruciating and Not satisfied at all at zero point and Nonexistent and Extremely satisfied at the 100 point. The table summarizes pain, satisfaction with function and satisfaction with esthetics at 12-months post loading.	12 months post-loading
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months	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. There were 38 total Adverse Events in 18 subjects out of 53 subjects. There were no SAEs related to procedure or device.	Measured at each study visit and throughout 12 months

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, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 12, 2019
• Study Completion (Actual): December 1, 2025

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dental Implants, Single-Tooth
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic 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