Tooth LossNCT02569671
Bone Level Tapered Multi-Center Study
A study testing Straumann Bone Level Tapered Implant - Immediate Placement and Straumann Bone Level Tapered Implant - Delayed Placement in people with Tooth Loss, run by Institut Straumann AG at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Straumann Bone Level Tapered Implant - Immediate Placement and Straumann Bone Level Tapered Implant - Delayed Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Implant Dentistry, University of Florida
Gainesville, Florida, 32610-0434
UCLA School of Dentistry
Los Angeles, California, 90095-1668
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this 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
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).
Read the 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.
- Conditions
- Tooth Loss
- Being tested
- Straumann Bone Level Tapered Implant - Immediate Placement, Straumann Bone Level Tapered Implant - Delayed Placement
- Keywords
- Dental Implants, Single-Tooth
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straumann Bone Level Tapered Implant - Immediate PlacementDevice
Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
Straumann Bone Level Tapered Implant - Delayed PlacementDevice
Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Placement - Test | Other | Straumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. Receives: Device: Straumann Bone Level Tapered Implant - Immediate Placement |
| Delayed Placement - Control | Other | Straumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. Receives: Device: Straumann Bone Level Tapered Implant - Delayed Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
Secondary outcomes (8)
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
Measured: 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:
- mesial to distal; 2) distal-buccal; 3) mid-buccal; 4) mesial-buccal; 5) distal-lingual; 6) mid-lingual; 7) mesial-lingual.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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: Measured at each study visit and throughout 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startMar 2016
- Primary completion12 Nov 2019
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David L. Cochran, DDS, PhD, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569671
- Sponsor's protocol ID
- CR 01/14
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2015
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02569671
- Acronym / sponsor ID
- CR 01/14
- Conditions
- Tooth Loss
- Keywords
- Dental Implants, Single-Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Placement - Test | Other | Device: Straumann Bone Level Tapered Implant - Immediate PlacementStraumann Bone Level Tapered Implant - Immediate Placement - Implant is placed at the time of tooth extraction to replace a single tooth. |
| Delayed Placement - Control | Other | Device: Straumann Bone Level Tapered Implant - Delayed PlacementStraumann Bone Level Tapered Implant - Delayed Placement - Implant is placed after 16-18 weeks of healing to replace a single tooth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straumann Bone Level Tapered Implant - Immediate PlacementImmediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth. | Device | Immediate Placement - Test |
| Straumann Bone Level Tapered Implant - Delayed PlacementDelayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth. | Device | Delayed Placement - Control |
Primary outcome
Mean Crestal Bone Level Change
Time frame: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level
8 secondary outcomes
Implant Success and Survival
Time frame: 12 months post-loading
Buccal Bone Dimensional Changes
Time frame: Measured at Implant loading and at screening and 12 months post-loading
Implant Measure as Measured by ISQ at Implant Surgery
Time frame: 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
Time frame: Implant Loading=implant surgery + 10 weeks (+/-3 weeks)
Implant Stability as Measured by ISQ at Final Restoration
Time frame: Final Restoration: 10 weeks post-loading (± 2 weeks)
Change in Soft Tissue Measurements
Time frame: 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
Time frame: 12 months post-loading
Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months
Time frame: Measured at each study visit and throughout 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Cochran, DDS, PhD, MS principal investigator
The University of Texas Health Science Center at San Antonio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann Bone Level Tapered Implant - Immediate Placement and Straumann Bone Level Tapered Implant - Delayed Placement in people with Tooth Loss, run by Institut Straumann AG at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Crestal Bone Level Change (time frame: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.